Male Stress Urinary Incontinence and Sexual Health
This study has been terminated.
(Too cumbersome to go through 2 review boards for a non-cancer study)
Information provided by (Responsible Party):
First received: June 21, 2011
Last updated: February 19, 2013
Last verified: February 2013
The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.
Device: Artificial urinary sphincter
Device: InVance Sling
Device: AdVance Sling
Device: Virtue Sling
||Male Stress Urinary Incontinence and Sexual Health
Primary Outcome Measures:
- Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Post-prostatectomy patients at least 6 months after either open radical retropubic prostatectomy or robot assisted laparoscopic prostatectomy with bothersome stress urinary incontinence will be initially screened with urodynamics, a 24 hour pad test, and a self questionnaire to assess how bothersome their incontinence is.
- Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.
- Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia.
- They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379378
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Craig Vance Comiter
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 21, 2011
||February 19, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Urinary Incontinence, Stress
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Lower Urinary Tract Symptoms
Signs and Symptoms