Male Stress Urinary Incontinence and Sexual Health

Prostate Cancer Clinical Trial

Official title:

Male Stress Urinary Incontinence and Sexual Health

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01379378
• Other study ID #: PROS0035
• Secondary ID: SU-06152011-7928
• Status: Withdrawn
• Phase: N/A
• First received: June 21, 2011
• Last updated: July 20, 2016
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Artificial urinary sphincter
Standard of care
• InVance Sling
Standard of care
• AdVance Sling
Standard of care
• Virtue Sling
Standard of care

Drug:
• Contigen
2.5-10 cc

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire		1 year	No
Primary	Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health		1 year	No