Conservative treatment for urinary incontinence in men after prostate surgery

ISRCTN	ISRCTN87696430
DOI	https://doi.org/10.1186/ISRCTN87696430
ClinicalTrials.gov number	NCT00632138
Secondary identifying numbers	HTA 03/14/03

Submission date: 09/07/2004
Registration date: 12/07/2004
Last edited: 26/10/2022

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

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-treatment-for-urinary-incontinence-after-prostate-surgery

Study website

Contact information

Dr Cathryn Glazener
Scientific

Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone	+44 (0)1224 553732
Email	c.glazener@abdn.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information can be found at https://www.charttrials.abdn.ac.uk/maps/pis.php
Scientific title	Conservative treatment for urinary incontinence in men after prostate surgery (MAPS): multi-centre randomised controlled trial of pelvic floor muscle training and biofeedback
Study acronym	MAPS
Study objectives	Randomised controlled trial of conservative treatment for urinary incontinence in men after prostate surgery. The hypothesis being tested in each group of men (in two parallel but separate trials) is that active conservative management will increase the proportion of continent men by 15% at one year after recruitment. The questions: 1. For men with urinary incontinence six weeks after radical prostatectomy, what is the clinical and cost-effectiveness of active conservative treatment delivered by a specialist continence physiotherapist or a specialist continence nurse compared with usual management? 2. For men with urinary incontinence six weeks after endoscopic resection of prostate, what is the clinical and cost-effectiveness of active conservative treatment delivered by a specialist continence physiotherapist or a specialist continence nurse compared with usual management? Please note that, as of 25/01/2008, the anticipated end date of this trial was updated from 31/05/2009 to 28/02/2010. Please note that the official scientific title of the trial was added as of 26/01/2009.
Ethics approval(s)	Multi-centre Research Ethics Committee for Scotland, approved on 11/06/2004 (ref: MREC/04/10/001)
Health condition(s) or problem(s) studied	Urinary incontinence
Intervention	Active Intervention: Pelvic floor muscle training and lifestyle advice with selective biofeedback (which may be digital or machine-mediated) with or without bladder training. It consists of four visits to a trained therapist who will teach the men the relevant exercises. Control Intervention: Lifestyle advice only Added as of 26/01/2009: Total duration of interventions: approximately 3 months
Intervention type	Other
Primary outcome measure	1. Primary clinical outcome: subjective report of urinary continence at 12 months 2. Primary measure of cost effectiveness: incremental cost per quality-adjusted life year
Secondary outcome measures	Clinical 1. Subjective report of continence or improvement of urinary incontinence at six months after randomisation, and improvement at 12 months 2. Number of incontinent episodes in previous week (objective, from diary) 3. Duration of incontinence (based on time of resolution relative to time of operation and randomisation) 4. Use of absorbent pads, penile collecting sheath, bladder catheter or bed/chair pads 5. Number and type of incontinence products used 6. Co-existence, cure or development of urgency or urge incontinence 7. Urinary frequency 8. Nocturia 9. Faecal incontinence (passive or urge) 10. Other bowel dysfunction (urgency, constipation, other bowel diseases) 11. Sexual function at 12 months (including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life and reason for change) Quality of life 1. Incontinence-specific quality of life outcome measure (10-point scale, International Consultation on Incontinence [ICI] questionnaire, Incontinence Quality of Life [I-QOL] questionnaire) 2. General health measures (SF-12® Health Survey, Euroqol EQ-5D) Use of health services for urinary incontinence 1. Need for alternative management for incontinence (e.g., surgery, drugs) 2. Use of GP, nurse, consultant urologist, physiotherapist Other use of health services 1. Visits to GP 2. Visits to practice nurse Effects of interventions 1. Use of pelvic floor muscle training (PFMT) 2. Lifestyle changes (weight, constipation, lifting, coughing, exercise) Economic measures 1. Patient costs (e.g., self care [e.g., pads, laundry], travel to health services, sick leave) 2. Cost of conservative trial treatment 3. Cost of alternative or additional NHS treatments (e.g., pads, catheters, drugs [eg adrenergic agonists, anticholinergics, oral medication for erectile dysfunction], hospital admissions or further surgery) 4. Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)
Overall study start date	01/12/2004
Completion date	28/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	800
Total final enrolment	853
Key inclusion criteria	1. Men (no age limits) who have urinary incontinence after prostate surgery (incontinence defined as a response indicating a loss of urine to either of two questions in the screening questionnaire: (how often do you leak urine? and how much urine do you leak?) 2. Informed consent 3. Ability to comply with intervention
Key exclusion criteria	1. Radiotherapy planned or given during the first three months after surgery for men with prostate cancer 2. Endoscopic resection of prostate carried out as palliation for outflow obstruction in advanced prostate cancer 3. Multiple sclerosis or Parkinson's disease 4. Inability to complete study questionnaires
Date of first enrolment	01/12/2004
Date of final enrolment	28/02/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Health Services Research Unit

Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

-
Aberdeen
AB24 3FX
Scotland
United Kingdom

Website	http://www.abdn.ac.uk/
"ROR"	https://ror.org/016476m91

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2009		Yes	No
Results article	results	23/07/2011		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.