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| Descriptive Information Fields | |||||
| 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] | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Randomized, Active Control | ||||
| Primary Outcome Measure † | Subjective report of urinary continence at 12 months [ Designated as safety issue: No ] Incremental cost per quality-adjusted year [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months [ Designated as safety issue: No ] Objective report of the number of incontinent episodes in the previous week from the urinary diary [ Designated as safety issue: No ] Duration of incontinence based on time of resolution relative to time of operation and randomization [ Designated as safety issue: No ] Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads [ Designated as safety issue: No ] Number and type of incontinence products used [ Designated as safety issue: No ] Co-existence, cure or development of urgency, or urge incontinence [ Designated as safety issue: No ] Urinary frequency [ Designated as safety issue: No ] Nocturia [ Designated as safety issue: No ] Fecal incontinence (passive or urge) [ Designated as safety issue: No ] Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases) [ Designated as safety issue: No ] Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change [ Designated as safety issue: No ] Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire [ Designated as safety issue: No ] General health measures [ Designated as safety issue: No ] Need for alternative management for incontinence (e.g., surgery or drugs) [ Designated as safety issue: No ] Use of GP, nurse, consultant urologist, or physiotherapist [ Designated as safety issue: No ] Visits to GP [ Designated as safety issue: No ] Visits to practice nurse [ Designated as safety issue: No ] Use of pelvic floor muscle training [ Designated as safety issue: No ] Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise) [ Designated as safety issue: No ] Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave) [ Designated as safety issue: No ] Cost of conservative trial treatment [ Designated as safety issue: No ] 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) [ Designated as safety issue: No ] Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months) [ Designated as safety issue: No ] |
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| Condition † | Precancerous/Nonmalignant Condition Prostate Cancer Psychosocial Effects/Treatment Sexual Dysfunction and Infertility Urinary Incontinence |
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| Intervention † | Procedure: biofeedback Procedure: exercise intervention Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 800 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00632138 | ||||
| Organization ID | CDR0000586420 | ||||
| Secondary IDs †† | ABROIN-MAPS, ISRCTN87696430 | ||||
| Study Sponsor † | Aberdeen Royal Infirmary | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 7, 2008 | ||||
| Last Updated Date | July 23, 2008 | ||||