Condition category
Urological and Genital Diseases
Date applied
04/06/2007
Date assigned
21/08/2007
Last edited
28/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof James Malone-Lee

ORCID ID

Contact details

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

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

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Change in 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

Publication citations

Additional files

Editorial Notes