Clinical Trial Results:
Pharmacological relaxation of the ureter when using access sheaths during ureterorenoscopy
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Summary
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EudraCT number |
2013-004475-13 |
Trial protocol |
DK |
Global end of trial date |
13 Jan 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Apr 2020
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First version publication date |
23 Apr 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
13.031
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Urological Research Center
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Sponsor organisation address |
Beriderbakken 4, Vejle, Denmark, 7100
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Public contact |
Søren Kissow Lildal, Urological Research Center, soerlild@rm.dk
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Scientific contact |
Søren Kissow Lildal, Urological Research Center, soerlild@rm.dk
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Sponsor organisation name |
Urological Research Center
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Sponsor organisation address |
Beriderbakken 4, Vejle, Denmark, 7100
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Public contact |
Palle Oster, Urological Research Center, Palle.Joern.Osther@rsyd.dk
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Scientific contact |
Palle Oster, Urological Research Center, Palle.Joern.Osther@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Jan 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Jan 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To investigate if addition of isoprenaline to the irrigation fluid makes it possible to insert an access sheath in the ureter of patients were insertion was impossible because of ureteral resistance.
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Protection of trial subjects |
The subjects were treated intraoperatively under full anaesthesia. The treatment does not likely cause any pain or discomfort. All patients were observed during perioperative admission and treated with regular relief of pain postoperatively if necessary as standard for this type of operation.
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Background therapy |
Endoscopical treatment of urinary tract stones. | ||
Evidence for comparator |
The comparator was saline irrigation. Saline irrigation is standard for this type of operation. | ||
Actual start date of recruitment |
01 Mar 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from august 2014 to january 2016 in the region of Southern Denmark. The study was terminated prematurely due to a lack of subjects. | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: Indication for diagnostic or therapeutic ureterorenoscopy. Men and women > 18 years Exclusion criteria: Known malignancies in the urinary tract New found malignancy during operation Allergy to isoprenaline 148 screened, 38 eligible, 10 included Subject were finally included during operation with written consent | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||
Blinding implementation details |
During operation the subject was included for randomization and treatment if there was a subjective resistance to insertion of the ureteral access sheath, evaluated by the surgeon. An OR nurse and a controller outside the OR room would the break a sealed envelope containing a pre-randomized treatment, either usual saline or saline with isoprenaline and prepare the irrigation fluid and bring it to the OR. The envelope would afterwards be sealed again until the end of the study.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Saline | |||||||||
Arm description |
Subjects randomized to regular endoscopic irrigation with saline | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Isoprenaline | |||||||||
Arm description |
Regular saline irrigation fluid with added isoprenaline | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Isoprenaline
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Investigational medicinal product code |
ISO
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Local use
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Dosage and administration details |
Isoprenaline 0,1 µg/ml Nacl irrigation fluid for irrigation during endoscopy in the upper urinary tract
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Baseline characteristics reporting groups
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Reporting group title |
Saline
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Reporting group description |
Subjects randomized to regular endoscopic irrigation with saline | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Isoprenaline
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Reporting group description |
Regular saline irrigation fluid with added isoprenaline | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Saline
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Reporting group description |
Subjects randomized to regular endoscopic irrigation with saline | ||
Reporting group title |
Isoprenaline
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Reporting group description |
Regular saline irrigation fluid with added isoprenaline | ||
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End point title |
Effect of isoprenaline on ureteral access sheath insertion success [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Success of insertion recorded during operation immediately after irrigation tested fluid.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The trial was no completed and therefore no statistical analysis can be performed as the number of included subjects is to small compared to what is necessary from power calculations. |
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Peroperatively by anesthesiology staff, postoperatively during admission by patient or ward staff or in the following period without timeframe by patient if any suspicious effects arise.
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Adverse event reporting additional description |
Adverse effects would be changes of pulse or blodpressure and related symptoms to this such as:
Headache, dizziness, tremor, palpitations, tachycardia, angina pectoris, flushing, nausea, vomiting, hypokalaemia.
Half life of interventional products is only a few minutes. Adverse effects are thus not to be expected after patient discharge.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
SAR/SUSAR | ||
Dictionary version |
1
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse effects were reported in this study. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was terminated before completion du to limited number of patients eligible for inclusion. 10 of 22 planned patients were included and completed. No adverse effects were reported.. | |||
