Plain English Summary
Not provided at time of registration
Trial website
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 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 trial start date
01/12/2004
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.