Evaluation of Clinical Outcome and Risk Factors for Failure of Single-incision Midurethral Short Tape Procedure (Solyx Tape) for Stress Urinary Incontinence.

STUDY

OBJECTIVE

To evaluate the clinical outcome and identify risk factors for failure of the Solyx (Boston Scientific Corporation, Marlborough, MA) single-incision sling (SIS) in the treatment of urodynamic stress incontinence (USI).

DESIGN

A retrospective observational study (Canadian Task Force classification II-2).

SETTING

A tertiary referral center.

PATIENTS: Patients diagnosed with USI without needing concurrent procedures that underwent continence surgery using the Solyx SIS from February 2015 to May 2017.

INTERVENTIONS: Anti-incontinence surgery.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome of this study was the rate of objective cure defined as the absence of demonstrable leakage of urine on the cough stress test and a 1-hour pad test weight of less than 2g. The secondary outcome was the rate of subjective cure defined as a negative response to Urinary Distress Inventory question 3 (no leakage on coughing, sneezing, or laughing) and the identification of the different risk factors of cure failure. A total of 113 patients were evaluated in the study. Postoperative USI and the 1-hour pad test significantly improved from 24.2 ± 26.9 gm (range, 19.1-29.3) to 2.5 ± 8.7 gm (range, 0.9-4.2); p <0.001 through 1 year. Data analysis showed an objective cure rate of 90% (102/113) and a subjective cure rate of 86% (97/113). USI recurred in 11 patients with no repeat surgery done becausesymptoms were tolerable to the patients. No patient had bladder outlet obstruction. Peak flow rates 23.7 ± 9.1 ml/s (20.0-27.4) and residual urine volume 38.5 ± 25.8 ml (29.8-47.2) were within normal limits with no significant changes. Previous anti-incontinent surgery, previous prolapsed surgery, intrinsic sphincter deficiency, maximum urethral closure pressure <40cm H2O, and neurogenic disease were significant risk factors for sling failure. Subjective assessment on the quality of life significantly improved (p <0.001).

CONCLUSION

The Solyx SIS is an effective and safe treatment option for women with USI, showing high objective and subjective cure rates with a low incidence of complications 1 year after treatment. The identified independent risk factors forfailure are related to poor urethral function and previous pelvic reconstructive surgery.