Urinary Incontinence
Conditions
Keywords
urinary incontinence, therapy, prostatectomy, prostate cancer
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Therapy
Pelvic Floor Muscle Exercises and Bladder control strategies
DEVICEPelvic Floor Electrical Stimulation
Pelvic Floor Electrical Stimulation daily for 8 weeks
BEHAVIORALBiofeedback
Pelvic Floor Muscle training via biofeedback
OTHERNo Treatment
No treatment
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
1. Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year. 2. One-week bladder diary with interpretable data and at least two incontinence episodes
Exclusion criteria
1. Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina 2. Cardiac pacemaker or implanted cardiac defibrillator 3. Current use of anticholinergic agents for detrusor instability 4. Folstein's Mini-Mental State Exam score below 24 (impaired mental status) 5. One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents. 6. Poorly controlled diabetes, defined as (glycosylated hemoglobin \> 9 within last 3 months). 7. Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation. 8. Urodynamic evaluation: Post-void residual volume greater than 200 mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Incontinence Episodes on Bladder Diary | 2 months | \[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes\] x 100% |
| Percent Change in Incontinence Episodes Per Week on Bladder Diary | 1 year | \[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes\] x 100% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Therapy Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies | 70 |
| 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 | 70 |
| Placebo Comparator No treatment control | 68 |
| Total | 208 |
Baseline characteristics
| Characteristic | Behavioral Therapy | Total | Placebo Comparator | Behavioral Therapy Plus Technologies |
|---|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 7.5 | 66.7 years STANDARD_DEVIATION 7.4 | 66.9 years STANDARD_DEVIATION 7.7 | 66.8 years STANDARD_DEVIATION 7 |
| Incontinence Episodes per Week | 28.1 Incontinence Episodes per Week STANDARD_DEVIATION 22 | 26.2 Incontinence Episodes per Week STANDARD_DEVIATION 22.6 | 24.8 Incontinence Episodes per Week STANDARD_DEVIATION 19.9 | 25.6 Incontinence Episodes per Week STANDARD_DEVIATION 26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 50 Participants | 16 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 155 Participants | 50 Participants | 54 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 70 Participants | 208 Participants | 68 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 2 / 70 | 0 / 68 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 | 0 / 68 |
Outcome results
Primary
Percent Change in Incontinence Episodes on Bladder Diary
\[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes\] x 100%
Time frame: 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Behavioral Therapy | Percent Change in Incontinence Episodes on Bladder Diary | 55 % change in episodes per week |
| Behavioral Therapy Plus Technologies | Percent Change in Incontinence Episodes on Bladder Diary | 51 % change in episodes per week |
| Placebo Comparator | Percent Change in Incontinence Episodes on Bladder Diary | 24 % change in episodes per week |
p-value: 0.001ANOVA
Primary
Percent Change in Incontinence Episodes Per Week on Bladder Diary
\[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes\] x 100%
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Behavioral Therapy | Percent Change in Incontinence Episodes Per Week on Bladder Diary | 50 % change in episodes per week |
| Behavioral Therapy Plus Technologies | Percent Change in Incontinence Episodes Per Week on Bladder Diary | 59 % change in episodes per week |
p-value: 0.32t-test, 1 sided