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| Sponsor: | Aberdeen Royal Infirmary |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00632138 |
Purpose
RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.
PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.
| Condition | Intervention | Phase |
|---|---|---|
|
Nonmalignant Neoplasm Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Urinary Incontinence |
Behavioral: exercise intervention Other: questionnaire administration Procedure: biofeedback Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS] |
| Estimated Enrollment: | 800 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to type of operation (radical prostatectomy vs transurethral resection of prostate). Patients are randomized to 1 of 2 treatment arms.
All patients keep a urinary diary at 3, 6, 9, and 12 months that includes frequency of urination (day and night), daily episodes of incontinence and quantity of loss, daily use of pads, and the need to change clothing or bedding. A Health Care Utilization Questionnaire will be obtained at 3 and 9 months. Additional questionnaires are obtained at baseline and 6 and 12 months.
The use of NHS services, pads, and practice of pelvic floor muscle training is documented in both groups using information from questionnaires and Urinary Diaries.
Six months after the last patient has been recruited, a check for Scottish men only is performed to compare self-reported operations, diagnoses, and hospital admissions with centrally collected data to validate a proportion of the data.
After completion of study treatment, patients are followed at 6 and 12 months.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Urinary incontinence at six weeks after prostate surgery
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United Kingdom | |
| Tameside General Hospital | Recruiting |
| Ashton-Under-Lyne, England, United Kingdom, OL6 9RW | |
| Contact: Contact Person 44-161-419-4299 | |
| Southmead Hospital | Recruiting |
| Bristol, England, United Kingdom, BS10 5NB | |
| Contact: Contact Person 44-117-950-5050 | |
| Bristol Royal Infirmary | Recruiting |
| Bristol, England, United Kingdom, BS2 8HW | |
| Contact: Contact Person 44-117-980-4118 | |
| Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting |
| Crewe, England, United Kingdom, CW1 4QJ | |
| Contact: Contact Person 44-127-061-2395 | |
| Royal Bolton Hospital | Recruiting |
| Farnworth, England, United Kingdom, BL4 0JR | |
| Contact: Contact Person 44-120-439-0445 | |
| King George Hospital | Recruiting |
| Ilford, Essex, England, United Kingdom, IG3 8YB | |
| Contact: Contact Person 44-208-8983-8000 | |
| Ipswich Hospital | Recruiting |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Contact: Contact Person 44-147-370-3689 | |
| Airedale General Hospital | Recruiting |
| Keighley, England, United Kingdom, BD20 6TD | |
| Contact: Contact Person 44-153-565-2511 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-206-6994 | |
| St. Mary's Hospital | Recruiting |
| London, England, United Kingdom, W2 1NY | |
| Contact: Contact Person 44-207-886-1006 | |
| Macclesfield District General Hospital | Recruiting |
| Macclesfield, England, United Kingdom, SK10 3BL | |
| Contact: Contact Person 44-161-419-4299 | |
| James Cook University Hospital | Recruiting |
| Middlesbrough, England, United Kingdom, TS4 3BW | |
| Contact: Contact Person 44-164-285-4712 | |
| Freeman Hospital | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Contact: Contact Person 44-191-233-6161 | |
| Norfolk and Norwich University Hospital | Recruiting |
| Norwich, England, United Kingdom, NR4 7UY | |
| Contact: Contact Person 44-160-328-6774 | |
| Nottingham City Hospital NHS Trust | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Contact Person 44-115-969-1169 | |
| Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting |
| Reading, England, United Kingdom, RG1 5AN | |
| Contact: Contact Person 44-118-322-8948 | |
| Queens Hospital | Recruiting |
| Romford, England, United Kingdom, RM3 0BE | |
| Contact: Contact Person 44-1708-345-533 | |
| Hope Hospital | Recruiting |
| Salford, England, United Kingdom, M6 8HD | |
| Contact: Contact Person 44-161-789-7373 | |
| Royal Hallamshire Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2JF | |
| Contact: Contact Person 44-114-226-1369 | |
| Lister Hospital | Recruiting |
| Stevenage, England, United Kingdom, SG1 4AB | |
| Contact: Contact Person 44-143-831-4333 | |
| Stepping Hill Hospital | Recruiting |
| Stockport, England, United Kingdom, SK2 7JE | |
| Contact: Contact Person 44-161-419-4299 | |
| Taunton and Somerset Hospital | Recruiting |
| Taunton, England, United Kingdom, TA1 5DA | |
| Contact: Contact Person 44-182-334-2111 | |
| Hillingdon Hospital | Recruiting |
| Uxbridge, England, United Kingdom, UB8 3NN | |
| Contact: Contact Person 44-189-523-8282 | |
| New Cross Hospital | Recruiting |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Contact: Contact Person 44-190-264-2822 | |
| Yeovil District Hospital | Recruiting |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Contact: Contact Person 44-193-538-4227 | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: Contact Person 44-122-455-0516 claire.cochran@abdn.ac.uk | |
| Ayr Hospital | Recruiting |
| Ayr, Scotland, United Kingdom, KA6 6DX | |
| Contact: Contact Person 44-129-261-0555 ext. 4354 | |
| Ninewells Hospital | Recruiting |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Contact: Contact Person 44-138-266-0111 ext. 35635 | |
| Queen Margaret Hospital - Dunfermline | Recruiting |
| Dunfermline, Scotland, United Kingdom, KY12 0SU | |
| Contact: Contact Person 44-138-362-3623 ext. 3143 | |
| Edinburgh Cancer Centre at Western General Hospital | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Contact: Contact Person 44-777-034-0960 | |
| Falkirk and District Royal Infirmary | Recruiting |
| Falkirk, Scotland, United Kingdom, FK1 5QE | |
| Contact: Contact Person 44-132-461-6026 | |
| Southern General Hospital | Recruiting |
| Glasgow, Scotland, United Kingdom, G51 4TF | |
| Contact: Contact Person 44-141-201-1511 | |
| Inverclyde Royal Hospital | Recruiting |
| Greenock, Scotland, United Kingdom, PA16 0XN | |
| Contact: Contact Person 44-147-563-3777 | |
| Raigmore Hospital | Recruiting |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| Contact: Contact Person 44-146-370-4000 ext. 5590 | |
| Pinderfields General Hospital | Recruiting |
| Wakefield, Scotland, United Kingdom, WF1 4DG | |
| Contact: Contact Person 44-192-421-2416 | |
| Morriston Hospital NHS Trust | Recruiting |
| West Glamorgen, Scotland, United Kingdom, SA6 6NL | |
| Contact: Contact Person 44-179-270-2222 | |
| University Hospital of Wales | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Contact: Contact Person 44-292-074-5094 | |
| Study Chair: | Cathryn Glazener, MD | Aberdeen Royal Infirmary |
More Information
| ClinicalTrials.gov Identifier: | NCT00632138 History of Changes |
| Obsolete Identifiers: | NCT00237029 |
| Other Study ID Numbers: | CDR0000586420, ABROIN-MAPS, ISRCTN87696430 |
| Study First Received: | March 7, 2008 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Unspecified |
|
sexual dysfunction and infertility psychosocial effects of cancer and its treatment prostate cancer benign prostatic hyperplasia urinary incontinence |
|
Neoplasms Urinary Incontinence Infertility Prostatic Neoplasms Urination Disorders Urologic Diseases Urological Manifestations |
Signs and Symptoms Genital Diseases, Male Genital Diseases, Female Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Diseases |