E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic urinary tract infection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059617 |
E.1.2 | Term | Overactive bladder |
E.1.2 | System Organ Class | 100000004857 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this study is to determine whether treatment with Nitrofurantoin improves average voided volume in MS and non-MS patients presenting with symptoms of overactive bladder and pyuria with a negative mid stream urine culture. |
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E.2.2 | Secondary objectives of the trial |
To determine whether treatment with Nitrofurantoin improves other symptoms of overactive bladder and indicators of infection and inflammation in MS and non-MS patients presenting with symptoms of overactive bladder and pyuria with a negative mid stream urine culture:
1. 24-hr-urinary frequency 2. Incontinence episodes per 24-hrs 3. Urgency score {Al Buheissi, 2008 1182 /id} 4 Pain Score 5. ICIQ-LUTS questionnaire 6. ICIQ-LUTSqol questionnaire 7. Urinary white cell concentration 8. Urinary epithelial cell concentration 9. Urinary epithelial cells showing bacterial adhesion 10. Urinary Il-6 levels 11. Quality of life (ICIQ) 12. Urinary pyuria, 12. Urinary bacterial culture 13. Urinary Il-6 levels 14. Urinary ATP levels
To determine whether pus cells are eliminated from the urine, < 10 wbc/ uL, after long term treatment with Nitrofurantoin.
To record side effects of treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A diagnosis of overactive bladder in MS and Non-MS patients 2. Adults aged >=18 years 3. Urinary urgency, with or without urge incontinence 4. Able to complete a bladder diary chart for at least three days in one week 5. Able to complete a symptom questionnaire 6. Pyuria on urinalysis showing ≥10 wbc µL-1 7. A negative result from culture of a midstream urine specimen on selective agar with a threshold of 105 cfu ml-1 8. Able to give informed consent
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E.4 | Principal exclusion criteria |
1. Age less than 18 years 2. Inability to consent 3. Bacteriuria of >105 cfu ml-1 identified by conventional MSU culture 4. Negative urine microscopy identified by < 10wbc/uL on a fresh, unspun sample of urine. 5. Known renal impairment - acute or chronic renal failure 6. Chronic lung disease 7. Glucose-6-phosphate deficiency 8. Acute porphyria 9. Allergy to Nitrofurantoin 10. The patient must not have taken part in other research within the previous six months and must not be participating in concurrent research. 11. The patient must not have taken part in previous studies of Nitrofurantoin 12. Pregnant or lactating females (Contraception is required in females and males who participate) 13. Intolerance to lactose 14. Concurrent use of other medicinal products which may interact with the study drug, including: Magnesium trisilicate, Sulphinpyrazone, Probenecid, Nalidixic acid, carbonic anhydrase inhibitors, and quinolone anti-infective drugs. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the change in average voided volume. |
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E.5.2 | Secondary end point(s) |
1. Change in 24-urinary incontinence 2. Change in 24-urinary frequency 3. Urgency score 4. Pain score 5. ICIQ-LUTS 6. ICIQ-LUTSqol 7. Urinary white cell concentration 8. Urinary epithelial cell concentration 9. Urinary epithelial cells showing bacterial adhesion 10. Urinary Il-6 levels 11. Urinary ATP 12. Qualitative urine culture 13. Quantitative urine culture
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is marked by the last clinic visit made by the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 11 |