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

This study has been completed.
Information provided by (Responsible Party):
Cook Identifier:
First received: July 10, 2009
Last updated: December 23, 2014
Last verified: December 2014
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.

Condition Intervention
Urinary Incontinence Prostate Cancer Procedure: Prostatectomy Device: Surgisis Male Sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Number of Continent Patients Post Prostatectomy [ Time Frame: 1 Month ]

Enrollment: 150
Study Start Date: November 2009
Study Completion Date: November 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Urethrovesical Sling
Surgisis Male Sling placed at the time of prostatectomy
Procedure: Prostatectomy Device: Surgisis Male Sling
Active Comparator: Control
Procedure: Prostatectomy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00937833

United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Texas
Urology of San Antonio Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Principal Investigator: Chandru Sundaram, MD Indiana Cancer Pavilion
  More Information

Responsible Party: Cook Identifier: NCT00937833     History of Changes
Other Study ID Numbers: 08-015
Study First Received: July 10, 2009
Results First Received: October 1, 2014
Last Updated: December 23, 2014

Keywords provided by Cook:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders processed this record on June 23, 2017