Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
This trial is active, not recruiting.
|Conditions||urinary incontinence, prostate cancer|
|Treatment||surgisis male sling|
|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|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Incontinence score post prostatectomy
time frame: 12 Months
time frame: 12 Months
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.
|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|
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