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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)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01379378
First received: June 21, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Device: Artificial urinary sphincter
Device: InVance Sling
Device: AdVance Sling
Device: Virtue Sling
Drug: Contigen

Study Type: Observational
Official Title: Male Stress Urinary Incontinence and Sexual Health

Resource links provided by NLM:


Further study details as provided by Stanford University:

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: 50
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Artificial urinary sphincter
    Standard of care
    Other Names:
    • urethral sphincter
    • American Medical Systems
    Device: InVance Sling
    Standard of care
    Other Names:
    • Urithrary sling
    • American Medical Systems
    Device: AdVance Sling
    Standard of care
    Other Name: Urithrary sling
    Device: Virtue Sling
    Standard of care
    Other Name: Coloplast
    Drug: Contigen
    2.5-10 cc
    Other Name: Bard
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Craig Vance Comiter Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01379378     History of Changes
Other Study ID Numbers: PROS0035, SU-06152011-7928
Study First Received: June 21, 2011
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Urinary Incontinence, Stress
Genital Diseases, Male
Genital Neoplasms, Male
Lower Urinary Tract Symptoms
Neoplasms
Neoplasms by Site
Prostatic Diseases
Signs and Symptoms
Urination Disorders
Urogenital Neoplasms
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 25, 2014