Back to resultsMale Stress Urinary Incontinence and Sexual Health
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Artificial urinary sphincter
InVance Sling
AdVance Sling
Virtue Sling
Contigen
Sponsored by
About this trial
This is an observational trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.
Exclusion Criteria:
- 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).
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01379378
Brief Title
Male Stress Urinary Incontinence and Sexual Health
Official Title
Male Stress Urinary Incontinence and Sexual Health
Study Type
Observational
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Artificial urinary sphincter
Other Intervention Name(s)
urethral sphincter, American Medical Systems
Intervention Description
Standard of care
Intervention Type
Device
Intervention Name(s)
InVance Sling
Other Intervention Name(s)
Urithrary sling, American Medical Systems
Intervention Description
Standard of care
Intervention Type
Device
Intervention Name(s)
AdVance Sling
Other Intervention Name(s)
Urithrary sling
Intervention Description
Standard of care
Intervention Type
Device
Intervention Name(s)
Virtue Sling
Other Intervention Name(s)
Coloplast
Intervention Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Contigen
Other Intervention Name(s)
Bard
Intervention Description
2.5-10 cc
Primary Outcome Measure Information:
Title
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
Time Frame
1 year
Title
Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.
Exclusion Criteria:
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).
Study Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Vance Comiter
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Male Stress Urinary Incontinence and Sexual Health
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