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A Parallel Randomized Clinical Trial Examining the Return of Urinary Continence after Robot-Assisted Radical Prostatectomy with or without a Small Intestinal Submucosa Bladder Neck Sling.
- Source :
-
The Journal of urology [J Urol] 2016 Jul; Vol. 196 (1), pp. 179-84. Date of Electronic Publication: 2016 Jan 16. - Publication Year :
- 2016
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Abstract
- Purpose: Urinary continence is a driver of quality of life after radical prostatectomy. In this study we evaluated the impact of a biological bladder neck sling on the return of urinary continence after robot-assisted radical prostatectomy.<br />Materials and Methods: This study compared early continence in patients undergoing robot-assisted radical prostatectomy with a sling and without a sling in a 2-group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0 to 1 pad per day) at 1 month postoperatively. Inclusion criteria were organ confined prostate cancer and a prostate specific antigen less than 15 ng/ml. Exclusion criteria were any prior surgery on the prostate, a history of neurogenic bladder and history of pelvic radiation. A chi-squared test was used for the primary outcome.<br />Results: A total of 147 patients were randomized (control 74, sling 73) and 92% were available for primary end point analysis at 1 month. There were no significant differences in baseline or perioperative data except that operating room time was 20.1 minutes longer for the sling group (p=0.04). The continence rate was similar between the control and sling groups at 1 month (47.1% vs 55.2%, p=0.34) and 12 months (86.7% vs 94.5%, p=0.15), respectively. Adverse events were similar between the control and sling groups (10.8% vs 13.7%, p=0.59).<br />Conclusions: The application of an absorbable urethral sling at robot-assisted radical prostatectomy was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence.<br /> (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Follow-Up Studies
Humans
Male
Middle Aged
Prospective Studies
Single-Blind Method
Treatment Outcome
Urinary Incontinence etiology
Postoperative Complications prevention & control
Prostatectomy methods
Prostatic Neoplasms surgery
Robotic Surgical Procedures
Suburethral Slings
Urinary Incontinence prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1527-3792
- Volume :
- 196
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Journal of urology
- Publication Type :
- Academic Journal
- Accession number :
- 26784645
- Full Text :
- https://doi.org/10.1016/j.juro.2016.01.010