Male Stress Urinary Incontinence and Sexual Health

NCT01379378 | Withdrawn DMC

• 2 other identifiers: PROS0035SU-06152011-7928
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire

  1 year

• Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health

  1 year

Interventions

Artificial urinary sphincter DEVICE

Standard of care

Also known as: urethral sphincter, American Medical Systems

InVance Sling DEVICE

Standard of care

Also known as: Urithrary sling, American Medical Systems

AdVance Sling DEVICE

Standard of care

Also known as: Urithrary sling

Virtue Sling DEVICE

Standard of care

Also known as: Coloplast

Contigen DRUG

2.5-10 cc

Also known as: Bard

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Urinary Sphincter, Artificial; glutaraldehyde-cross-linked collagen

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Craig Vance Comiter

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

US (1)