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    Clinical Trial Results:
    Antibiotic treatment for intermittent bladder catheterisation: A randomised controlled trial of once daily prophylaxis (The AnTIC study)

    Summary
    EudraCT number
    		 2013-002556-32
    Trial protocol
    		 GB  
    Global end of trial date
    23 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2018
    First version publication date
    09 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ANTIC:6672
    Additional study identifiers
    ISRCTN number
    		 ISRCTN67145101
    US NCT number
    		 NCT02145338
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Freeman Hospital, Newcastle upon Tyne, United Kingdom, NE7 7DN
    Public contact
    Robert Pickard, Newcastle University, 44 1912137139, robert.pickard@ncl.ac.uk
    Scientific contact
    Robert Pickard, Newcastle University, 44 1912137139, robert.pickard@ncl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question was to determine whether use of antibiotic prophylaxis over 12 months resulted in a clinically significant (real and worthwhile) reduction in the rate of symptomatic, antibiotic-treated urinary tract infection (UTI) suffered by people performing intermittent self-bladder catheterisation compared to no prophylaxis. We also calculated which treatment strategy gives best value for money to patients and the NHS by measuring the cost per urinary infection avoided by use of antibiotic prophylaxis. During the first 12 months of the trial we determined whether recruitment to planned trial duration and sample size was going to succeed by monitoring numbers of randomised participants. Specific objectives for the first phase of the study was to find out how quickly individual research sites could begin to recruit patients to the trial, to find out how many eligible patients are identified and how many of those agree to participate per month.
    Protection of trial subjects
    The investigational medicinal products (IMP) used in the trial are all licensed in dosage and form for use in prophylaxis against UTI in the UK and are standard care for this indication. From this it was judged that from an IMP perspective the risk to participants was no higher that of standard care. Any adverse effects associated with the use of antibiotic prophylaxis related to individual agents or changes to normal bacterial flora, were described and minimized by carefully worded trial information given to participants to enable selection of the individually most appropriate agent and information concerning use of oral probiotics. Participants with symptomatic urinary tract infection were encouraged to also take a catheter specimen of urine (CSU) to their treating clinician for local analysis according to local protocols.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 404
    Worldwide total number of subjects
    404
    EEA total number of subjects
    404
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    223
    From 65 to 84 years
    172
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between November 2013 and January 2016 through 51 primary and secondary care NHS research sites in England and Scotland. Sites were grouped around six UK hubs in Newcastle upon Tyne, Wakefield, Cambridge, Bristol, Southampton, Aberdeen and Glasgow.

    Pre-assignment
    Screening details
    		 Participants were identified when attending secondary care clinics, by search of NHS health records and from commercial organisations providing NHS care. Participants meeting inclusion criteria and willing to participate were consented to take part in the study. Those already taking antibiotic prophylaxis underwent a 3-month washout period.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study design did not allow blinding of participants, clinicians or local research teams to allocation, although outcome assessors including laboratory staff and members of the central trial team involved in outcome adjudication were blinded to allocated group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Antibiotic Prophylaxis
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trimethoprim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Trimethoprim (100mg)

    Investigational medicinal product name
    Nitrofurantoin
    Investigational medicinal product code
    Other name
    Aratoin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Nitrofurantoin 50 mg (or 100 mg dependent on participant weight).

    Investigational medicinal product name
    Cefalexin
    Investigational medicinal product code
    Other name
    Ospexin, Tenkorex, Kiflone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Cefalexin 250mg.

    Arm title
    		 No Prophylaxis
    Arm description
    		 -
    Arm type
    		 Standard Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Antibiotic Prophylaxis No Prophylaxis
    Started
    203
    201
    Completed
    203
    201
    Period 2
    Period 2 title
    Primary analysis point
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Antibiotic Prophylaxis
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trimethoprim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Trimethoprim (100mg)

    Investigational medicinal product name
    Nitrofurantoin
    Investigational medicinal product code
    Other name
    Aratoin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Nitrofurantoin 50 mg (or 100 mg dependent on participant weight).

    Investigational medicinal product name
    Cefalexin
    Investigational medicinal product code
    Other name
    Ospexin, Tenkorex, Kiflone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Cefalexin 250mg.

    Arm title
    		 No Prophylaxis
    Arm description
    		 -
    Arm type
    		 Standard Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Antibiotic Prophylaxis No Prophylaxis
    Started
    203
    201
    Completed
    181
    180
    Not completed
    22
    21
         Consent withdrawn by subject
    16
    14
         Death
    -
    1
         Excluded from analysis insufficient data
    6
    6
    Period 3
    Period 3 title
    12 month follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Antibiotic Prophylaxis
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trimethoprim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Trimethoprim (100mg)

    Investigational medicinal product name
    Nitrofurantoin
    Investigational medicinal product code
    Other name
    Aratoin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Nitrofurantoin 50 mg (or 100 mg dependent on participant weight).

    Investigational medicinal product name
    Cefalexin
    Investigational medicinal product code
    Other name
    Ospexin, Tenkorex, Kiflone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily Cefalexin 250mg.

    Arm title
    		 No Prophylaxis
    Arm description
    		 -
    Arm type
    		 Standard Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Antibiotic Prophylaxis No Prophylaxis
    Started
    181
    180
    Completed
    181
    180

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Antibiotic Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    No Prophylaxis
    Reporting group description
    		 -

    Reporting group values
    		 Antibiotic Prophylaxis No Prophylaxis Total
    Number of subjects
    		 203 201 404
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 114 109 223
        From 65-84 years
    		 86 86 172
        85 years and over
    		 3 6 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.1 ± 17.0 60.1 ± 15.6 -
    Gender categorical
    Units: Subjects
        Female
    		 88 87 175
        Male
    		 115 114 229
    Number of UTI episodes
    Number of UTI episodes suffered in the 12 months prior to randomisation
    Units: Subjects
        <4
    		 71 78 149
        >=4
    		 132 123 255
    Cause of bladder dysfunction
    Units: Subjects
        Neurological
    		 80 78 158
        Non-neurological
    		 123 123 246
    Type of intermittent catheterisation
    Units: Subjects
        By self
    		 201 198 399
        By spouse/carer
    		 1 2 3
        Missing
    		 1 1 2
    Planned future duration of need for intermittent catheterisation
    Units: Subjects
        Between 1 and 2 years
    		 0 4 4
        Between 2 and 5 years
    		 0 1 1
        Indefinite
    		 182 181 363
        Not known
    		 20 14 34
        Missing
    		 1 1 2
    Route of intermittent catheterisation
    Units: Subjects
        Urethra
    		 196 195 391
        Mitrofanoff
    		 6 5 11
        Missing
    		 1 1 2
    Type of catheter used
    Units: Subjects
        Single use
    		 200 199 399
        Re-useable
    		 2 2 4
        Missing
    		 1 0 1
    Hydrophillic coated catheter used?
    Units: Subjects
        No
    		 9 8 17
        Yes
    		 189 192 381
        Missing
    		 5 1 6
    Main functional reason for requiring intermittent catheterisation
    Units: Subjects
        Bladder outlet obstruction
    		 49 56 105
        Bladder failure (underactivity)
    		 139 128 267
        Bladder augmentation / replacement
    		 13 16 29
        Missing
    		 2 1 3
    Central laboratory culture of urine at baseline
    Units: Subjects
        Negative
    		 93 84 177
        Positive
    		 76 77 153
        Missing
    		 34 40 74
    Creatinine clearance
    Units: CrCl (mL/min)
        median (inter-quartile range (Q1-Q3))
    		 89.8 (68.6 to 121.4) 99.1 (71.9 to 124.2) -
    Frequency of CISC (/24 hours)
    Frequency of clean intermittent self catheterisation in a 24 hour period.
    Units: Number of times
        arithmetic mean (standard deviation)
    		 3.8 ± 2.2 4.1 ± 2.9 -
    Episodes of UTI in last 12 months
    Episodes of UTI experienced by participant in the last 12 months
    Units: Episodes
        median (inter-quartile range (Q1-Q3))
    		 4.0 (3.0 to 6.0) 4.0 (3.0 to 7.0) -
    Positive urine culture reports in the last 12 months
    Units: Number
        median (inter-quartile range (Q1-Q3))
    		 2.0 (1.0 to 4.0) 2.0 (1.0 to 4.0) -
    Months use of antibiotic prophylaxis in last 12 months
    Units: Months
        median (inter-quartile range (Q1-Q3))
    		 0.0 (0.0 to 1.0) 0.0 (0.0 to 1.0) -

    End points

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    End points reporting groups
    Reporting group title
    Antibiotic Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    No Prophylaxis
    Reporting group description
    		 -
    Reporting group title
    Antibiotic Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    No Prophylaxis
    Reporting group description
    		 -
    Reporting group title
    Antibiotic Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    No Prophylaxis
    Reporting group description
    		 -

    Primary: Occurrence of symptomatic antibiotic-treated UTI

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    End point title
    		 Occurrence of symptomatic antibiotic-treated UTI
    End point description
    Occurrence of clinical UTI was defined as the presence of symptoms together with taking a treatment course of antibiotic for UTI. This was measured by participant return of a UTI record for each event, as well as 3-monthly participant questionnaire and 3-monthly trial visit case report form (CRF) completed by the local research team.
    End point type
    Primary
    End point timeframe
    Occurrence of symptomatic antibiotic-treated UTI over 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    181
    180
    Units: UTI
        All eligible
    235
    450
    Statistical analysis title
    		 Symptomatic antibiotic treated UTI
    Statistical analysis description
    Results of performing Poisson regression (incidence rate ratio approach) for primary outcome: number of symptomatic antibiotic-treated UTI.
    Comparison groups
    Antibiotic Prophylaxis v No Prophylaxis
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Incidence Rate Ratio
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04

    Primary: Occurrence of symptomatic antibiotic-treated UTI (baseline <4)

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    End point title
    		 Occurrence of symptomatic antibiotic-treated UTI (baseline <4)
    End point description
    Sub group analysis for participants with Baseline UTI <4
    End point type
    Primary
    End point timeframe
    Occurrence of symptomatic antibiotic-treated UTI over 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    69
    68
    Units: UTI
        Baseline UTI <4
    55
    118
    Statistical analysis title
    		 Symptomatic antibiotic treated UTI
    Comparison groups
    Antibiotic Prophylaxis v No Prophylaxis
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Incidence Rate Ratio
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Primary: Occurence of symptomatic antibiotic treated UTI (baseline >=4)

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    End point title
    		 Occurence of symptomatic antibiotic treated UTI (baseline >=4)
    End point description
    Sub group analysis for participants with baseline UTI >=4
    End point type
    Primary
    End point timeframe
    Occurrence of symptomatic antibiotic-treated UTI over 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    112
    112
    Units: UTI
        Baseline episodes of UTI >=4
    180
    332
    Statistical analysis title
    		 symptomatic antibiotic-treated UTI
    Comparison groups
    Antibiotic Prophylaxis v No Prophylaxis
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson Regression
    Parameter type
    		 Incidence Rate Ratio
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Primary: Occurrence of symptomatic antiobiotic-treated UTI (adjusted for days at risk)

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    End point title
    		 Occurrence of symptomatic antiobiotic-treated UTI (adjusted for days at risk)
    End point description
    Secondary analysis of primary outcome, adjusted for days at risk
    End point type
    Primary
    End point timeframe
    Occurrence of symptomatic antibiotic-treated UTI over 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    181
    180
    Units: UTI
        All eligible
    235
    450
    Statistical analysis title
    		 Symptomatic antibiotic-treated UTI
    Statistical analysis description
    Adjusted for days at risk
    Comparison groups
    No Prophylaxis v Antibiotic Prophylaxis
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson Regression
    Parameter type
    		 Incidence Rate Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04

    Primary: Occurrence of symptomatic antiobiotic-treated UTI (adjusted for days at risk and stratification)

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    End point title
    		 Occurrence of symptomatic antiobiotic-treated UTI (adjusted for days at risk and stratification)
    End point description
    Secondary analysis of primary outcome adjusted for days at risk and stratification factors
    End point type
    Primary
    End point timeframe
    Occurrence of symptomatic antibiotic-treated UTI over 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    181
    180
    Units: UTI
        All eligible
    235
    450
    Statistical analysis title
    		 Occurrence of symptomatic antiobiotic-treated UTI
    Comparison groups
    Antibiotic Prophylaxis v No Prophylaxis
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson Regression
    Parameter type
    		 Incidence Rate Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04

    Secondary: Treatment Satisfaction (TSQM)

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    End point title
    		 Treatment Satisfaction (TSQM)
    End point description
    Satisfaction with treatment measured using the Treatment Satisfaction with Medication Questionnaire (TSQM). Maximum rating = 100 for each domain. Using ANCOVA modelling to compare arms (adjusting for stratification factors): Effectiveness p<0.001 Side-effects p=0.94 Convenience p<0.001 Overall p<0.001 Overall satisfaction score for prophylaxis participants was 74. The TSQM is not validated for 'no treatment' strategies in an open-label RCT setting but overall this group rated mean overall satisfaction as 63.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    144 [1]
    109 [2]
    Units: Scale Score
    arithmetic mean (standard deviation)
        Effectiveness
    78.0 ± 19.1
    66.3 ± 19.5
        Side-effects
    67.4 ± 23.4
    67.2 ± 24.2
        Convenience
    88.9 ± 13.9
    78.2 ± 21.4
        Overall satisfaction
    73.8 ± 25.4
    63.0 ± 24.3
    Notes
    [1] - Effectiveness n=144, Side-effects n=22, Convenience n=144, Overall n=143
    [2] - Effectiveness n=108, Side-effects n=32, Convenience n=109, Overall n=109
    No statistical analyses for this end point

    Secondary: eGFR at Baseline and 12 months

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    End point title
    		 eGFR at Baseline and 12 months
    End point description
    Estimated Glomerular Filtration Rate (eGFR) measuring kidney function with comparison between arms
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    200 [3]
    197 [4]
    123 [5]
    140 [6]
    Units: ml/minute
        arithmetic mean (standard deviation)
    86.6 ± 30.2
    88.0 ± 26.1
    82.3 ± 30.0
    83.3 ± 27.6
    Notes
    [3] - Baseline
    [4] - Baseline
    [5] - 12 months
    [6] - 12 months
    No statistical analyses for this end point

    Secondary: Change in eGFR from Baseline

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    End point title
    		 Change in eGFR from Baseline
    End point description
    Change in estimated glomerular filtration rate (eGFR) at 12 months from baseline.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    123
    138
    Units: ml/minute
        arithmetic mean (standard deviation)
    -2.1 ± 15.0
    -3.4 ± 14.2
    Statistical analysis title
    		 Change in eGFR at 12 months
    Comparison groups
    No Prophylaxis v Antibiotic Prophylaxis
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 ANCOVA
    Confidence interval

    Secondary: ALT at Baseline and 12 months

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    End point title
    		 ALT at Baseline and 12 months
    End point description
    Serum alanine transaminase (ALT) measured at baseline and 12 months, with comparison between arms.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    198 [7]
    188 [8]
    118 [9]
    135 [10]
    Units: U/L
        arithmetic mean (standard deviation)
    24.7 ± 19.9
    24.1 ± 15.6
    26.1 ± 19.1
    24.0 ± 14.1
    Notes
    [7] - Baseline
    [8] - Baseline
    [9] - 12 months
    [10] - 12 months
    No statistical analyses for this end point

    Secondary: Change in ALT at 12 months

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    End point title
    		 Change in ALT at 12 months
    End point description
    Change in serum alanine transaminase (ALT) at 12 months
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Antibiotic Prophylaxis No Prophylaxis
    Number of subjects analysed
    117
    128
    Units: U/L
        arithmetic mean (standard deviation)
    1.2 ± 19.5
    -0.3 ± 14.7
    Statistical analysis title
    		 Change in ALT at 12 months
    Comparison groups
    Antibiotic Prophylaxis v No Prophylaxis
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported for the duration of the trial and for 4 weeks after the trial intervention was stopped.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Verbatim
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Antibiotic Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    No Prophylaxis
    Reporting group description
    		 -

    Serious adverse events
    		 Antibiotic Prophylaxis No Prophylaxis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 203 (9.85%)
    22 / 201 (10.95%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Bilateral pulmonary embolism
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Polypharmacy
    Additional description: Falls and confusion, left sided pneumonia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Car accident
    Additional description: Admitted for medical observation after car accident
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Admitted to hospital for observation and review
    Additional description: CT head - new intracranial changes
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain, dizziness and vomiting
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Collapsed while driving
    Additional description: ?CVA, ?seizure disorder
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache and nausea
    Additional description: Emergency admission to hospital
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache and right-sided neck pain
    Additional description: Shunt malfunction
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical fall
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rigors
    Additional description: On parenteral nutrition
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: bilateral femoral fractures and right distal tibial fracture
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizures and collapse
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unable to catheterise Mitrofanoff adequately
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasovagal episode
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 201 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Abdominal aortic aneurysm
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma attack
    Additional description: Acute asthma attack and anxiety
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest infection
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 201 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Triple bypass surgery
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dysphagia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right-sided weakness attributed to somatoform disorder
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transverse myelitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Neuromyelitis optica
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal cancer metastatic
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain due to faecal loading
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain/constipation
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal impaction
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforated appendix
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Recurrent vomiting and generalised abdominal discomfort
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Adverse drug reaction
    Additional description: Asymptomatic highly raised serum liver enzyme alanine transaminase (ALT)
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder cancer
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematuria post TURP
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria post intravesical botulinum toxin
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trans-urethral resection of bladder tumour
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sub-meatal and urethral strictures
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Follicular thyroid cancer
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fall
    Additional description: Fall resulting in fractured spine
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute chronic back pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    Additional description: Right foot, diagnosed with Charcot's joint.
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post microdiscectomy recurrent lumbar pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ankle stabilisation
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured left quadriceps tendon
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Hickman line infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous gastric feeding tube site infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Antibiotic Prophylaxis No Prophylaxis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 203 (31.53%)
    55 / 201 (27.36%)
    Vascular disorders
    painful varicocele
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Ruptured blood vessel left foot
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    ACE
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Biopsy for microcalcification of lump, left breast
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Biopsy of skin lesion
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Bladder pressure test for neobladder
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Botox treatment
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Corrective surgery to right foot
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Cystoscopy
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective admission for dilatation of mitrofanoff and neo bladder washout
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective admission for SCS insertion
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective admission for stricture dilatation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective day case for embolisation of varicocele
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective microdisectomy
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective perineal proctectomy
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective surgery to investigate thickening in bladder wall
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective TURP
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective TURP leading to long term catheterisation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Endoscopy
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Fasciectomy (routine planned admission)
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Elective admission for revision of Mitrofanoff
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Knee replacement
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 201 (0.50%)
         occurrences all number
    1
    1
    Elective mastoidectomy
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Neo vascular surgery (AMD) to right eye
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Botox injection for overactive bladder
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 201 (0.00%)
         occurrences all number
    2
    0
    Sacral nerve stimulation for overactive bladder
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective thyroid surgery
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Elective below knee amputation
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Rectal irrigation for constipation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Biopsy of prostate
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Transurethral prostatectomy
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Abnormal GGT noted on checking routine liver function
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Achilles
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Admitted to EAU for headache
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Adverse reaction to Nitrofurantoin
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 201 (0.00%)
         occurrences all number
    2
    0
    Attended AE ?DVT
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Attended AE for ? TIA
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Attended ED with ? chest pain. Discharged same night
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Attended ED with increase swollen leg, woozy and light-headed
    Additional description: possible side effect of Citalopram
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Attended ED for ? obstructed bowel. Discharged same day
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Migraine (issue with shunt?)
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Attended A&E for ? cause
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Blackout whilst driving
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Car accident
    Additional description: car reversed into patient
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Cat bite
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Collapse of right leg
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Lower back pain and groin pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Contusion (head)
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Decline in WCC
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Generalised joint pain of sudden onset
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Head cold
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Hoarseness (exacerbation)
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    pain right wrist
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    pain and discomfort in toes of both feet
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Reaction to Nitrofurantoin prescribed for UTI
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 201 (0.50%)
         occurrences all number
    1
    1
    Elevated potassium
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Vulval lumps
    Additional description: Antibiotic given for ? infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Thinning hair
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Blotchy rash on back
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Rash on inner arms, palms and back of neck
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Patient reported collapse on the way to buy papers
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Pulled VP shunt
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Pressure sore
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    2
    Pruritis vulvae
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    PV bleed
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Reaction to flucloxacillin
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Reaction to trimethoprim
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Scalp itchiness
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Sore throat
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Stomach discomfort
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Stopped prophylactic cephalexin due to stomach issues
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Stopped prophylactic antiobiotics on microbiologist advice
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Weight loss
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Breathless
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Chest infection
         subjects affected / exposed
    0 / 203 (0.00%)
    2 / 201 (1.00%)
         occurrences all number
    0
    2
    Chesty cough
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Common cold
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Cough (exacerbation)
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Bronchiectasis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 203 (1.48%)
    3 / 201 (1.49%)
         occurrences all number
    3
    3
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Investigations
    Ultrasound investigation
    Additional description: Found hydrocele in right testicle and bilateral epydidimal cysts
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Routine cystoscopy
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Urodynamics
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Burn right foot, infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Fall due to back pain after sneezing
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Fractured ribs due to fall
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Injury to urethra from catheter
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Post op redness of second toe
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Severe pain right knee due to fall
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 201 (0.50%)
         occurrences all number
    1
    1
    Night sweats increased
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Epileptic fit
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Decline in WBC and platelets
    Additional description: Study drug discontinued
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Increased tinnitus following VP shunt revision
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Anteria Uveitis left eye
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Fluid behind eyes bilaterally
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Blurred vision
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea and sickness
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 201 (0.50%)
         occurrences all number
    1
    4
    Diarrhoea and vomiting
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Mild intermittent nausea
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    4
    0
    Nausea
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Pancreatitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Viral gastroenteritis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Two actinic keratoses on left side of upper nose
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Rash on chest, legs and feet
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
    Additional description: Removed with complete excision
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Blotchy rash
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Exacerbation of dermatitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Exacerbation of leg ulcers
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    2
    Itchy rash
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Itchy skin with excoriation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Admitted to Emergency assessment unit for query renal colic
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Attended ED for UTO
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Decline in renal function noted in biochemistry
    Additional description: Prophylaxis stopped
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Frank haematuria caused by kink in hi catheter
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Frank haematuria requiring flexible cystoscopy
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Frank haematuria with pre-existing non functioning right kidney
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Haematuria and retention
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Left renal cyst increase in size to 5cm
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Pain in transplanted kidney
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Frank blood in urine
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Periodic urethritis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Renal pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Thickening of bladder wall
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Acupuncture for back pain
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Back pain/fall
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Cervical spondylosis (exacerbation)
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Tennis elbow, cortisone injection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Decompression of L4 and L5 through degenerative changes
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Pain base of right thumb
    Additional description: exacerbation osteoarthritis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Infections and infestations
    Dental abscess
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    2
    Oral infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Oral thrush and constipation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Thrush in mouth
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Yeast infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Septic toe
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Sinus infection
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Slight infection to left teste
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 201 (0.50%)
         occurrences all number
    0
    1
    Tennis elbow, infected soft tissue
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Thrush
         subjects affected / exposed
    2 / 203 (0.99%)
    1 / 201 (0.50%)
         occurrences all number
    2
    1
    Tonsillitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0
    Wound infection to knee after fall
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 201 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2013
    Widening of inclusion criteria to include those who had had one serious UTI – in line with options that would be offered in standard care. More frequent participant contact – to help participants as much as possible to complete UTI log and avoid ascertainment bias. Payment of any prescription charge to avoid participants being out of pocket. £20 gift to participants on study entry Use of calculated creatinine clearance rather than eGFR – in line with recent NHS guidance for use of nitrofurantoin as UTI prophylaxis.
    13 May 2014
    The protocol was updated to make it clear that washout participants should be consented at the beginning of the washout period, but not randomised until the washout period was complete The protocol was also amended to clarify that an active, symptomatic UTI did not exclude a participant from the study and that consent to participate could still be taken, but that the UTI should be treated before a participant could be randomised.
    14 May 2014
    Update to the contraindications section of the SmPC for Nitrofurantoin concerning patients with kidney dysfunction with an eGFR of less than 45 ml/minute. The study protocol and all study documentation were amended to reflect this update.
    30 Jul 2015
    Change to the protocol to allow sites to send a second invitation letter to participants who had not responded to the initial invitation to the study.
    17 Aug 2016
    Update to clarify the wording around the approved RSI for the study. The RSI contained in section 4.8 of the SmPC for the three antibiotics used in the study was submitted to MHRA for approval. The updated SmPC for nitrofurantoin, trimethoprim and cefalexin were included in the appendices of the new protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29766842
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