N/A
N=150
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Urinary Incontinence · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00937833 ↗Enrolled (actual)
150
Serious AEs
1.4%
Results posted
Nov 2014
Primary outcome: Primary: Number of Continent Patients Post Prostatectomy — 37; 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prostatectomy (Procedure); Surgisis Male Sling (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Cook Group Incorporated
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Continent Patients Post Prostatectomy |
37; 32 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00937833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.