A randomised, double blind validation of the significance of occult pyuria for the symptoms of the overactive bladder

INTERVENTION: Trade Name: Macrodantin Pharmaceutical Form: Capsule* INN or Proposed INN: Nitrofurantoin CAS Number: 67‐20‐9 Other descriptive name: Nitrofurantoin Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: The overactive bladder ; MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder PRIMARY OUTCOME: Main Objective: The aim of this study is to determine whether treatment with Nitrofurantoin improves incontinence episodes per 24‐hrs in patients presenting with symptoms of over active bladder with a negative mid stream urine culture. Primary end point(s): Change in average 24‐hr incontinence episodes Secondary Objective: To determine whether treatment with Nitrofurantoin improves other symptoms of over active bladder: ; 1.24‐urinary frequency ; 2.Urgency score ; 3.Average voided volume ; 4.Quality of life (I‐Qol) ; ; 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 ; 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