Condition category
Urological and Genital Diseases
Date applied
09/07/2004
Date assigned
12/07/2004
Last edited
12/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/maps/

Contact information

Type

Scientific

Primary contact

Dr Cathryn Glazener

ORCID ID

Contact details

Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553732
c.glazener@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00632138

Protocol/serial number

HTA 03/14/03

Study information

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

Acronym

MAPS

Study hypothesis

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

Multi-centre Research Ethics Committee for Scotland, approved on 11/06/2004 (ref: MREC/04/10/001)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at https://www.charttrials.abdn.ac.uk/maps/pis.php

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2004

Overall trial end date

28/02/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

800

Participant 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

Recruitment start date

01/12/2004

Recruitment end date

28/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research Unit
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

-
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19635340
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21741700

Publication citations

  1. Protocol

    Dorey G, Glazener C, Buckley B, Cochran C, Moore K, Developing a pelvic floor muscle training regimen for use in a trial intervention., Physiotherapy, 2009, 95, 3, 199-209, doi: 10.1016/j.physio.2009.03.003.

  2. Results

    Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, Hagen S, Kilonzo M, McDonald A, McPherson G, Moore K, Norrie J, Ramsay C, Vale L, N'Dow J, Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials., Lancet, 2011, 378, 9788, 328-337, doi: 10.1016/S0140-6736(11)60751-4.

Additional files

Editorial Notes