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The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.
The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation.
Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Therapy | Experimental | Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) |
|
| Behavioral Therapy Plus Technologies | Experimental | Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) |
|
| Placebo Comparator | Placebo Comparator | No treatment control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Therapy | Behavioral | Pelvic Floor Muscle Exercises and Bladder control strategies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Incontinence Episodes on Bladder Diary | [(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100% | 2 months |
| Percent Change in Incontinence Episodes Per Week on Bladder Diary | [(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100% | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia S Goode, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21224456 | Result | Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972. | |
| 37070660 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Therapy | Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies |
| FG001 | Behavioral Therapy Plus Technologies | Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks Biofeedback: Pelvic Floor Muscle training via biofeedback |
| FG002 | Placebo Comparator | No treatment control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Therapy | Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies |
| BG001 | Behavioral Therapy Plus Technologies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Incontinence Episodes on Bladder Diary | [(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100% | Posted | Mean | 95% Confidence Interval | % change in episodes per week | 2 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Therapy | Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation of Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia S Goode, MD | University of Alabama at Birmingham | 2055587064 | pgoode@uabmc.edu |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
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| Pelvic Floor Electrical Stimulation | Device | Pelvic Floor Electrical Stimulation daily for 8 weeks |
|
| Biofeedback | Behavioral | Pelvic Floor Muscle training via biofeedback |
|
| No Treatment | Other | No treatment |
|
| 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. |
Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback
| BG002 | Placebo Comparator | No treatment control |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Incontinence Episodes per Week | Mean | Standard Deviation | Incontinence Episodes per Week |
|
| OG002 | Placebo Comparator | No treatment control |
|
|
|
| Primary | Percent Change in Incontinence Episodes Per Week on Bladder Diary | [(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100% | This outcome was to measure treatment durability. The no-treatment control group completed the study after the primary outcome was collected at 2 months. At that time, they were offered treatment for this burdensome condition outside the study. Only the 2 active treatment groups continued in the study for 1 full year. | Posted | Mean | 95% Confidence Interval | % change in episodes per week | 1 year |
|
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Behavioral Therapy Plus Technologies | Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks Biofeedback: Pelvic Floor Muscle training via biofeedback | 0 | 70 | 2 | 70 |
| EG002 | Placebo Comparator | No treatment control | 0 | 68 | 0 | 68 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D013812 | Therapeutics |
| D030141 | Feedback, Psychological |