This trial is active, not recruiting.

Conditions urinary incontinence, prostate cancer
Treatment surgisis male sling
Sponsor Cook
Start date November 2009
End date October 2013
Trial size 150 participants
Trial identifier NCT00937833, 08-015, 350017


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (subject)
Primary purpose prevention
surgisis male sling SurgiSIS Biodesign
The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
(No Intervention)

Primary Outcomes

Incontinence score post prostatectomy
time frame: 12 Months

Secondary Outcomes

time frame: 12 Months

Eligibility Criteria

Male participants at least 18 years old.

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 > 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 a prostate size >100 cc as measured on digital rectal examination or transrectal ultrasound. - 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 by a negative 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.

Additional Information

Official title Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Principal investigator Chandru Sundaram, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Cook.