A randomised, double blind validation of the significance of occult pyuria for the symptoms of the overactive bladder - The Overactive bladder and Nitrofurantoin trial
- Conditions
- The overactive bladderMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2007-003398-24-GB
- Lead Sponsor
- The Whittington Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1.Adults aged >=18 years
2.Males
3.Females
4.Symptoms of frequency = 8 per day; urgency with or without urge incontinence.
5.Able to complete a bladder diary chart for at least three days in one week
6.Able to complete a symptom questionnaire
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.Age less than 18 years,
2.Inability to consent.
3.Bactiuria 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method