title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana.
authors.forename: Clinton D
authors.initials: CD
authors.lastname: Bahler
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana.
authors.forename: Chandru P
authors.initials: CP
authors.lastname: Sundaram
authors.affiliation: The Urology Place, San Antonio, Texas.
authors.forename: Naveen
authors.initials: N
authors.lastname: Kella
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Lucas
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana.
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Boger
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Gardner
authors.affiliation: Department of Urology, Indiana University, Indianapolis, Indiana. Electronic address: miokoch@iupui.edu.
authors.forename: Michael O
authors.initials: MO
authors.lastname: Koch
mesh_terms: D000368:Aged; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000601:surgery*; D065287:Robotic Surgical Procedures; D016037:Single-Blind Method; D053825:Suburethral Slings; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology / Q000517:prevention & control*
keywords: laparoscopy; prostatic neoplasms; robotics; urinary incontinence