Trial Outcomes & Findings for Conservative Treatment of Postprostatectomy Incontinence (NCT NCT00212264)

NCT ID: NCT00212264

Last Updated: 2016-04-11

Results Overview

\[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes\] x 100%

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 208 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2016-04-11

Participant Flow

Participant milestones

Measure	Behavioral Therapy Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies	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	Placebo Comparator No treatment control
Overall Study STARTED	70	70	68
Overall Study COMPLETED	58	54	64
Overall Study NOT COMPLETED	12	16	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conservative Treatment of Postprostatectomy Incontinence

Baseline characteristics by cohort

Measure	Behavioral Therapy n=70 Participants Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies	Behavioral Therapy Plus Technologies n=70 Participants 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	Placebo Comparator n=68 Participants No treatment control	Total n=208 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	66.8 years STANDARD_DEVIATION 7.0 • n=7 Participants	66.9 years STANDARD_DEVIATION 7.7 • n=5 Participants	66.7 years STANDARD_DEVIATION 7.4 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	70 Participants n=7 Participants	68 Participants n=5 Participants	208 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	54 Participants n=7 Participants	50 Participants n=5 Participants	155 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Incontinence Episodes per Week	28.1 Incontinence Episodes per Week STANDARD_DEVIATION 22.0 • n=5 Participants	25.6 Incontinence Episodes per Week STANDARD_DEVIATION 26.0 • n=7 Participants	24.8 Incontinence Episodes per Week STANDARD_DEVIATION 19.9 • n=5 Participants	26.2 Incontinence Episodes per Week STANDARD_DEVIATION 22.6 • n=4 Participants

PRIMARY outcome

Timeframe: 2 months

[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%

Outcome measures

Measure	Behavioral Therapy n=70 Participants Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies	Behavioral Therapy Plus Technologies n=70 Participants 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	Placebo Comparator n=68 Participants No treatment control
Percent Change in Incontinence Episodes on Bladder Diary	55 % change in episodes per week Interval 44.0 to 66.0	51 % change in episodes per week Interval 37.0 to 65.0	24 % change in episodes per week Interval 10.0 to 39.0

PRIMARY outcome

Timeframe: 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.

[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%

Outcome measures

Measure	Behavioral Therapy n=70 Participants Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies	Behavioral Therapy Plus Technologies n=70 Participants 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	Placebo Comparator No treatment control
Percent Change in Incontinence Episodes Per Week on Bladder Diary	50 % change in episodes per week Interval 40.0 to 61.0	59 % change in episodes per week Interval 45.0 to 73.0	—

Adverse Events

Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Therapy Plus Technologies

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Behavioral Therapy n=70 participants at risk Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies	Behavioral Therapy Plus Technologies n=70 participants at risk 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	Placebo Comparator n=68 participants at risk No treatment control
Gastrointestinal disorders Irritation of Hemorrhoids	0.00% 0/70 • 1 year	2.9% 2/70 • 1 year	0.00% 0/68 • 1 year

Additional Information

Patricia S Goode, MD

University of Alabama at Birmingham

Phone: 2055587064

Email: pgoode@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place