Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OAB/AB/07
Study information
Scientific title
A randomised, double-blind validation of the significance of occult pyuria for the symptoms of the overactive bladder
Acronym
NOD (Nitrofurantoin in Overactive Detrusor)
Study hypothesis
Study hypothesis amended as of 11/09/2007:
The aim of this study is to determine whether treatment with nitrofurantoin improves total 24 hour incontinence episodes in patients presenting with symptoms of overactive bladder, who have significant numbers of inflammatory cells in their urine but a negative urine culture.
Study hypothesis provided at time of registration:
The aim of this study is to determine whether treatment with pivmecillinam improves total 24 hour incontinence episodes in patients presenting with symptoms of overactive bladder, who have significant numbers of inflammatory cells in their urine but a negative urine culture.
Ethics approval
Whittington and Moorfields Research Ethics Committee, 07/05/2008, ref: 08/H0721/23
Study design
Randomised placebo-controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Overactive bladder
Intervention
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 daily for 6 weeks
Please note that this change is due to difficulty in finding suitable placebo for the pivmecillinam preparation.
Interventions provided at time of registration:
Intervention group: Pivmecillinam will be administered orally at a dose of 400 mg twice daily
Control group: Placebo administered orally, twice daily
Intervention type
Drug
Phase
Not Applicable
Drug names
Nitrofurantoin
Primary outcome measures
Number of incontinence episodes per 24 hours, assessed by bladder diary chart recorded by the patients during the intervention
Secondary outcome measures
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
Overall trial start date
01/10/2007
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 in each arm
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Archway Campus
London
N19 5LW
United Kingdom
Sponsor information
Organisation
The Whittington Hospital NHS Trust (UK)
Sponsor details
Magdala Avenue
Highgate Hill
London
N19 5LW
United Kingdom
+44 (0)207 288 5269
james.malone-lee@ucl.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Whittington Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary