Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212264
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2005-09-13
Brief Title:
Conservative Treatment of Postprostatectomy Incontinence
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Conservative Treatment of Postprostatectomy Incontinence
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None