Male Stress Urinary Incontinence and Sexual Health

NCT ID: NCT01379378

Last Updated: 2016-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Interventions

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Artificial urinary sphincter

Standard of care

Intervention Type DEVICE

InVance Sling

Standard of care

Intervention Type DEVICE

AdVance Sling

Standard of care

Intervention Type DEVICE

Virtue Sling

Standard of care

Intervention Type DEVICE

Contigen

2.5-10 cc

Intervention Type DRUG

Other Intervention Names

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urethral sphincter American Medical Systems Urithrary sling American Medical Systems Urithrary sling Coloplast Bard

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Vance Comiter

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-06152011-7928

Identifier Type: OTHER

Identifier Source: secondary_id

PROS0035

Identifier Type: -

Identifier Source: org_study_id

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