Overactive bladder Urological and Genital Diseases Overactive bladder
Conditions
Interventions
Interventions amended as of 23/11/2007:
Intervention group: Nitrofurantoin (Brand Name: Macrodantin®) 100 mg orally b.d (twice daily) for 6 weeks
Control group: Placebo administered orally, twice da
Sponsors
The Whittington Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Both males and females 3. Symptoms of frequency more than or equal to 8 per day; 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
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years 2. Inability to consent 3. Bactiuria of >105 Colony Forming Unit (CFU) /ml identified by conventional Midstream Urine Specimen (MSU) culture 4. Negative urine microscopy identified by <10 White Blood Cells (WBC)/uL on a fresh, unspun sample of urine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of incontinence episodes per 24 hours, assessed by bladder diary chart recorded by the patients during the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure amended as of 11/09/2007: 1. To determine whether treatment with nitrofurantoin improves other symptoms of over active bladder, the following will be assessed: 1.1. 24-urinary frequency 1.2. Urgency score assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.3. Average voided volume assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.4. Quality of life (I-Qol) assessed at 2 weekly intervals until the end of the trial at 6 weeks 2. Assessment to determine whether pus cells are eliminated from the urine, <10 WBC/uL, after long-term treatment with nitrofurantoin. This will be measured at 2 weekly intervals until the end of the trial at 6 weeks 3. Recording side effects of treatment Secondary outcome measures provided at time of registration: 1. To determine whether treatment with Pivmecillinam improves other symptoms of over active bladder, the following will be assessed: 1.1. 24-urinary frequency 1.2. Urgency score assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.3. Average voided volume assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.4. Quality of life (I-Qol) assessed at 2 weekly intervals until the end of the trial at 6 weeks 2. Assessment to determine whether pus cells are eliminated from the urine, <10 WBC/uL, after long-term treatment with Pivmecillinam. This will be measured at 2 weekly intervals until the end of the trial at 6 weeks 3. Recording side effects of treatment | — |
Countries
United Kingdom
Outcome results
None listed