Evaluation of services for urinary dysfunction

ISRCTN	ISRCTN94747416
DOI	https://doi.org/10.1186/ISRCTN94747416
Protocol serial number	G9410491
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr C McGrother
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	6000
Key inclusion criteria	Urinary dysfunction measured on a postal questionnaire (incontinence, nocturia, frequent voiding, urinary urgency)
Key exclusion criteria	1. Pregnancy 2. Malignancy 3. Fistula 4. Those already in receipt of treatment
Date of first enrolment	01/06/1996
Date of final enrolment	31/03/2002

Department of Epidemiology and Public Health

Leicester
LE1 2TP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2002		Yes	No