Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
NCT ID: NCT00632138
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2005-01-31
2011-07-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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exercise intervention
questionnaire administration
biofeedback
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Men who have undergone a radical prostatectomy for prostate cancer or men who have undergone a transurethral resection of the prostate for benign prostatic hypertrophy
* Urinary incontinence at six weeks after prostate surgery
* Incontinence is defined as a response on the screening questionnaire indicating a loss of urine including how often and how much
PATIENT CHARACTERISTICS:
* Able to comply with intervention
* Able to complete study questionnaires
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No referral for formal therapy (teaching of pelvic floor muscle training) due to prostate surgery
* No concurrent or planned radiotherapy during the first 3 months after surgery
* No palliative endoscopic resection of prostate due to outflow obstruction for advanced prostate cancer
MALE
No
Sponsors
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Aberdeen Royal Infirmary
OTHER
Principal Investigators
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Cathryn Glazener, MD
Role: STUDY_CHAIR
Aberdeen Royal Infirmary
Locations
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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
Countries
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References
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Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.
Other Identifiers
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CDR0000586420
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN87696430
Identifier Type: -
Identifier Source: secondary_id
ABROIN-MAPS
Identifier Type: -
Identifier Source: org_study_id
NCT00237029
Identifier Type: -
Identifier Source: nct_alias