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

PurposeUrinary continence is a driver of quality of life after radical prostatectomy. The purpose of this study was to evaluate the impact of a biologic bladder neck sling on postoperative return of urinary continence after robot-assisted radical prostatectomy (RARP). Materials and MethodsThis study compared early continence in patients undergoing RARP with a sling and without a sling in a two group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0-1 pads per day) at 1 month postoperative. Inclusion criteria included organ-confined prostate cancer and a prostatespecific antigen <15. Exclusion criteria included any prior surgery on the prostate, history of neurogenic bladder, and history of prior pelvic radiation. A chi-squared test was used for the primary outcome. ResultsA total of 147 patients were randomized (control=74, sling=73), and 92% were available for primary endpoint 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 control and sling groups at both 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 control and sling groups (10.8% vs. 13.7%, P=0.59). 3 ConclusionsThe application of an absorbable urethral sling at the time of RARP was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence.4

To sling or not to sling? Impact of intraoperative sling procedures during radical prostatectomy on postoperative continence outcomes: A systematic review and meta‐analysis

“…95%CI: −0.54 to 3.13) (Figure 3). Study by Bahler et al was not included in this meta-analysis as the study did not report confidence interval for the data, however, the study coincides with our finding 18 (n = 104) (MD: −0.4; p = 0.61; 95% CI: not reported).…”

“…10,[18][19][20][22][23][24] However, with continence definition of ≤ 1pad/day, there was a low to moderate-quality evidence that sling procedures did not reduce the risk of incontinence at 1 month (RR:1.12; 95%CI: 1.00 to 1.24), 3 months (RR:1.07; 95%CI: 0.95 to 1.21), 6 months (RR:1.01; 95%CI: 0.95 to 1.07), and 12 months (RR: 1.02; 95%CI: 0.93 to 1.13) postoperatively (n = 794) (Figure 2). 10,18,22,24,26 Sling procedure did not reduce the time taken to achieve continence with zero pad/day definition 20,25 (n = 296) (MD: 1.29;…”

“…Length of operation [Bahler, 2016;Kojima, 2014;Cestari, 2015 reduces the time taken to achieve continence with ≤ 1 pad/day definition but not with zero pad/day definition.…”

How can we prevent postprostatectomy urinary incontinence by patient selection, and by preoperative, peroperative, and postoperative measures? International Consultation on Incontinence‐Research Society 2018

“…The main limitations of all the above studies have been related to small numbers and nonrandomization to a control group. Subsequently, Bahler et al failed to show any benefit of using SIS sling at the time of RP on continence status compared with controls at 1‐month follow‐up in a randomized controlled trial. In this study, zero pad status was observed in 13 of 67 in the sling group vs 13 of 68 in the control group.…”

Precision surgery and genitourinary cancers

“…Reference Technique Preservation Friedlander 18 Bladder neck sparing Lim 30 Retzius sparing Reinforcement Lee 24 Bladder neck plication stitch Bahler 22 Small intestinal submucosa bladder neck sling Lei 19 Selective suture ligation of dorsal venous complex Patel 20 Periurethral suspension stitch Nguyen 21 Urethral sling fashioned from autologous vas deferens Dal Moro 27 Complete Reconstruction of the Posterior Urethral Support (CORPUS) Reconstruction Propiglia 23 Total anatomical reconstruction Student 25 Advanced reconstruction of vesicourethral support (ARVUS) Jeong 26 1-step posterior reconstruction Hurtes 28 Anterior retropubic suspension with posterior reconstruction Coelho 29 Modified posterior reconstruction showing that the procedure is effective in long term cancer control, even in patients with high-risk disease (Table 2). 43e49 Theoretically, robot-assisted surgery should be the ideal model to determine the impact and limitations of "surgical precision" providing better ergonomic for the surgeon, particularly during reconstructive steps, better vision and magnification during dissection of the prostate and surrounding anatomical details.…”