Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
- Conditions
- Nonmalignant NeoplasmProstate CancerPsychosocial Effects of Cancer and Its TreatmentSexual DysfunctionUrinary Incontinence
- Registration Number
- NCT00632138
- Lead Sponsor
- Aberdeen Royal Infirmary
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective report of urinary continence at 12 months Incremental cost per quality-adjusted year
- Secondary Outcome Measures
Name Time Method Use of pelvic floor muscle training General health measures Need for alternative management for incontinence (e.g., surgery or drugs) Use of GP, nurse, consultant urologist, or physiotherapist Visits to GP Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months Objective report of the number of incontinent episodes in the previous week from the urinary diary Duration of incontinence based on time of resolution relative to time of operation and randomization Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads Number and type of incontinence products used Co-existence, cure or development of urgency, or urge incontinence Urinary frequency Nocturia Fecal incontinence (passive or urge) Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases) Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire Visits to practice nurse Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise) Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave) Cost of conservative trial treatment Cost of alternative or additional NHS treatments (e.g., pads, catheters, drugs [e.g., adrenergic agonists, anticholinergics, or oral medication for erectile dysfunction], hospital admissions, or further surgery) Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)
Trial Locations
- Locations (37)
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
Scroll for more (27 remaining)Tameside General Hospital🇬🇧Ashton-Under-Lyne, England, United Kingdom