- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379378
Male Stress Urinary Incontinence and Sexual Health
July 20, 2016 updated by: Stanford University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
Time Frame: 1 year
|
1 year
|
Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Craig Vance Comiter, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
July 22, 2016
Last Update Submitted That Met QC Criteria
July 20, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROS0035
- SU-06152011-7928 (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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