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Brief Title: Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
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]
Study ID: NCT00632138
Brief Summary: 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.
Detailed Description: OBJECTIVES: * To establish whether conservative physical treatment delivered personally by a trained health professional results in better urinary and other outcomes compared with standard management in men who are incontinence after prostate surgery. 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. * Arm I (intervention group): At 6 weeks after surgery, patients undergo an assessment of their symptoms by a physiotherapist or continence nurse. All patients are taught pelvic floor muscle training and men with urgency or urge incontinence are also taught bladder training. Pelvic floor training consists of 3 maximum pelvic floor contractions in 3 positions (standing, sitting, and lying down) twice a day, lifting of the pelvic floor while walking, tightening of the pelvic muscles before activities, and tightening of the pelvic muscles after urinating to squeeze out any last drops. The strength of the pelvic floor contractions is monitored by biofeedback involving digital anal assessment and relaying the information back to men in order that they know when they are performing contractions correctly and to inform them when they are increasing the strength or duration of their contractions. Therapists may use machine-mediated biofeedback with an anal biofeedback probe at their discretion in addition to digital anal assessment. Bladder training consists of gradually delaying urination by pelvic floor muscle contraction and distracting activities to teach the bladder to hold increasing volumes of urine. Patients also receive a customized Pelvic Floor Exercise Booklet describing pelvic floor muscle training in addition to a customized Lifestyle Advice Booklet giving general lifestyle advice. Patients have reinforcement sessions at approximately 2, 6, and 12 weeks after the first appointment. * Arm II (control group): Patients receive a customized Lifestyle Advice Booklet containing supportive lifestyle advice only (without reference to pelvic floor muscle training) by mail following randomization. Patients do not receive formal assessment or treatment but will be able to access usual care and routine NHS services if they feel they need help, including written advice if this is part of routine hospital care. 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Tameside General Hospital, Ashton-Under-Lyne, England, United Kingdom
Southmead Hospital, Bristol, England, United Kingdom
Bristol Royal Infirmary, Bristol, England, United Kingdom
Mid Cheshire Hospitals Trust- Leighton Hopsital, Crewe, England, United Kingdom
Royal Bolton Hospital, Farnworth, England, United Kingdom
King George Hospital, Ilford, Essex, England, United Kingdom
Ipswich Hospital, Ipswich, England, United Kingdom
Airedale General Hospital, Keighley, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
St. Mary's Hospital, London, England, United Kingdom
Macclesfield District General Hospital, Macclesfield, England, United Kingdom
James Cook University Hospital, Middlesbrough, England, United Kingdom
Freeman Hospital, Newcastle-Upon-Tyne, England, United Kingdom
Norfolk and Norwich University Hospital, Norwich, England, United Kingdom
Nottingham City Hospital, Nottingham, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England, United Kingdom
Queens Hospital, Romford, England, United Kingdom
Hope Hospital, Salford, England, United Kingdom
Royal Hallamshire Hospital, Sheffield, England, United Kingdom
Lister Hospital, Stevenage, England, United Kingdom
Stepping Hill Hospital, Stockport, England, United Kingdom
Taunton and Somerset Hospital, Taunton, England, United Kingdom
Hillingdon Hospital, Uxbridge, England, United Kingdom
New Cross Hospital, Wolverhampton, England, United Kingdom
Yeovil District Hospital, Yeovil, England, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Ayr Hospital, Ayr, Scotland, United Kingdom
Ninewells Hospital, Dundee, Scotland, United Kingdom
Queen Margaret Hospital - Dunfermline, Dunfermline, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom
Falkirk and District Royal Infirmary, Falkirk, Scotland, United Kingdom
Southern General Hospital, Glasgow, Scotland, United Kingdom
Inverclyde Royal Hospital, Greenock, Scotland, United Kingdom
Raigmore Hospital, Inverness, Scotland, United Kingdom
Pinderfields General Hospital, Wakefield, Scotland, United Kingdom
Morriston Hospital NHS Trust, West Glamorgen, Scotland, United Kingdom
University Hospital of Wales, Cardiff, Wales, United Kingdom
Name: Cathryn Glazener, MD
Affiliation: Aberdeen Royal Infirmary
Role: STUDY_CHAIR