Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
12/09/2007
Prospective/Retrospective
Retrospectively 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

Dr C McGrother

ORCID ID

Contact details

Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9410491

Study information

Scientific title

Acronym

Study hypothesis

The objective of the phase I trial is to compare a new Continence Nurse Practitioner (CNP) led service with existing service provision for individuals with incontinence and lower urinary tract symptoms in terms of symptom severity, associated factors, impact and economic implications. Treatment in the nursing service lasts eight weeks. The new nursing service delivers a package of evidence based interventions for the provision of continence care which are protocol driven.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Urinary dysfunction

Intervention

1. Existing service provision: general practitioners and primary health care team
2. Nurse led service provision: new service instituting evidence based assessment and interventions provided by specially trained nurses

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

An independent interview is carried out 13 weeks and 26 weeks after randomisation in both arms of the trial . This measures symptom severity, associated factors, impact (social and psychological) and economic aspects of the condition.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1996

Overall trial end date

31/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Urinary dysfunction measured on a postal questionnaire (incontinence, nocturia, frequent voiding, urinary urgency)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6000

Participant exclusion criteria

1. Pregnancy
2. Malignancy
3. Fistula
4. Those already in receipt of treatment

Recruitment start date

01/06/1996

Recruitment end date

31/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12133054

Publication citations

  1. Results

    Shaw C, Matthews RJ, Perry SI, Assassa RP, Williams K, McGrother C, Dallosso H, Jagger C, Mayne C, Clarke M, , Validity and reliability of an interviewer-administered questionnaire to measure the severity of lower urinary tract symptoms of storage abnormality: the Leicester Urinary Symptom Questionnaire., BJU Int., 2002, 90, 3, 205-215.

Additional files

Editorial Notes