Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Primary Purpose
Urinary Incontinence, Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostatectomy
Surgisis Male Sling
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence focused on measuring prostate cancer, prostatectomy, incontinence
Eligibility Criteria
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.
Sites / Locations
- Indiana University School of Medicine
- Urology of San Antonio Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Urethrovesical Sling
Control
Arm Description
Surgisis Male Sling placed at the time of prostatectomy
Prostatectomy
Outcomes
Primary Outcome Measures
Number of Continent Patients Post Prostatectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT00937833
First Posted
July 10, 2009
Last Updated
December 23, 2014
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00937833
Brief Title
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Official Title
Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Prostate Cancer
Keywords
prostate cancer, prostatectomy, incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urethrovesical Sling
Arm Type
Experimental
Arm Description
Surgisis Male Sling placed at the time of prostatectomy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Prostatectomy
Intervention Type
Device
Intervention Name(s)
Surgisis Male Sling
Primary Outcome Measure Information:
Title
Number of Continent Patients Post Prostatectomy
Time Frame
1 Month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandru Sundaram, MD
Organizational Affiliation
Indiana Cancer Pavilion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Urology of San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
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