Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

Prostate Cancer Clinical Trial

Official title:

Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937833
• Other study ID #: 08-015
• Secondary ID: 350017
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: December 23, 2014
• Start date: November 2009
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have organ confined prostate cancer.

• Patients must have PSA< 15.

• Patients must have clinical stage prostate cancer < cT3.

• Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.

• Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.

• Patients must be at least 18 years of age.

Exclusion Criteria:

• Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.

• Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.

• Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.

• Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.

• Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.

• Patients must not have a prior history of radiation to the pelvis.

• Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.

• Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Procedure:
• Prostatectomy

Device:
• Surgisis Male Sling

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Urology of San Antonio Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Continent Patients Post Prostatectomy		1 Month	No