Chronic urinary tract infection. MedDRA version: 16.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Nitrofurantoin
Product Name: Nitrofurantoin
Product Code: PL 12762/0049
Pharmaceutical Form: Capsule
INN or Proposed INN: Ni
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 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 ;Primary end point(s): The primary outcome measure is the change in average voided volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed