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

ISRCTN	ISRCTN20127069
DOI	https://doi.org/10.1186/ISRCTN20127069
Secondary identifying numbers	OAB/AB/07

Submission date: 04/06/2007
Registration date: 21/08/2007
Last edited: 07/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof James Malone-Lee
Scientific

Department of Medicine
Clerkenwell Building
Archway Campus
Highgate Hill
London
N19 5LW
United Kingdom

Study information

Study design	Randomised placebo-controlled double-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised, double-blind validation of the significance of occult pyuria for the symptoms of the overactive bladder
Study acronym	NOD (Nitrofurantoin in Overactive Detrusor)
Study objectives	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(s)	Whittington and Moorfields Research Ethics Committee, 07/05/2008, ref: 08/H0721/23
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Nitrofurantoin
Primary outcome measure	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 study start date	01/10/2007
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30 in each arm
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Archway Campus

London
N19 5LW
United Kingdom

Sponsor information

The Whittington Hospital NHS Trust (UK)
Hospital/treatment centre

Magdala Avenue
Highgate Hill
London
N19 5LW
England
United Kingdom

Phone	+44 (0)207 288 5269
Email	james.malone-lee@ucl.ac.uk
"ROR"	https://ror.org/01ckbq028

Funders

Funder type

Hospital/treatment centre

The Whittington Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

07/06/2017: No publications found, verifying study status with principal investigator.