NCT00212264

Conservative Treatment of Postprostatectomy Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Therapy	Pelvic Floor Muscle Exercises and Bladder control strategies
DEVICE	Pelvic Floor Electrical Stimulation	Pelvic Floor Electrical Stimulation daily for 8 weeks
BEHAVIORAL	Biofeedback	Pelvic Floor Muscle training via biofeedback
OTHER	No Treatment	No treatment

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-09-01
• Completion: 2011-08-01
• First posted: 2005-09-21
• Last updated: 2016-04-11
• Results posted: 2016-04-11

Locations

1 site across 1 country: United States