Status:
COMPLETED
Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
Lead Sponsor:
Aberdeen Royal Infirmary
Conditions:
Nonmalignant Neoplasm
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
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 th...
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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00632138
Start Date
January 1 2005
End Date
July 1 2011
Last Update
August 7 2013
Active Locations (37)
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1
Tameside General Hospital
Ashton-under-Lyne, England, United Kingdom, OL6 9RW
2
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
3
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
4
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, United Kingdom, CW1 4QJ