Could the vaginal wall sling still have a role after FDA's warning? the functional outcomes at 20 years

Ester Illiano; Francesco Trama; Alessandro Marchesi; Consuelo Fabi; Stefano Brancorsini; Elisabetta Costantini

doi:10.1177/17562872221084391

Could the vaginal wall sling still have a role after FDA's warning? the functional outcomes at 20 years

Ther Adv Urol. 2022 Mar 7:14:17562872221084391. doi: 10.1177/17562872221084391. eCollection 2022 Jan-Dec.

Authors

Ester Illiano¹, Francesco Trama², Alessandro Marchesi¹, Consuelo Fabi³, Stefano Brancorsini³, Elisabetta Costantini¹

Affiliations

¹ Andrology and Urogynecology Clinic, Santa Maria Terni Hospital, University of Perugia, Terni, Italy.
² Andrology and Urogynecology Clinic, Santa Maria Terni Hospital, University of Perugia, Piazzale Tristano di Joanuccio 1, Terni 05100, Italy.
³ Department of Experimental Medicine, Section of Terni, University of Perugia, Terni, Italy.

Abstract

Introduction: Aims of this study were to evaluate the functional outcomes of a vaginal wall sling technique in patients with stress urinary incontinence at 20 years after surgery and to evaluate the patient's satisfaction after the surgical procedure.

Material and methods: This was a prospective single-center study on patients with stress urinary incontinence who underwent in situ vaginal sling surgery. Presurgery evaluation included history, pelvic examination, and urodynamic test. All patients completed Urogenital Distress Inventory-6 (UDI-6) questionnaire. They underwent checkups at 1, 3, 6, and 12 months postoperatively and then annually. The sling was created by making a rectangle (15-20 × 25 mm) on the anterior vaginal wall and it was reinforced by one roll of Marlex mesh on each side of the sling. The sutures were passed through the vagina at the suprapubic level after suprapubic incision, above the rectus fascia and tied without excessive tension.

Results: From May 1996 to May 2002, 40 women underwent vaginal wall sling surgery for stress urinary incontinence. Last visit was performed on 20 women between March 2020 and April 2020. Median follow-up was 251.3 months (20.9 years) (range = 204.3-285.4 months). The success rate after 5 years of surgical procedure was 80%; over 5 years, the objective cure rate was 45%. Considering only the group of 13 patients with pure stress urinary incontinence, the objective cure rate decreased to 38%, in particular 7 years after surgery. Women who did not resolve their urinary incontinence needed to undergo a new treatment. At over 5 years after surgery, there was an increase in urgency (p = 0.001) and voiding symptoms (p = 0.008) and urgency urinary incontinence (UUI) (p = 0.04). Ninety-five percent were very much worse or much worse according to the Patient Global Impression of Improvement (PGI-I) scale.

Conclusion: The in situ vaginal wall sling does not guarantee good long-term functional outcomes in women with stress urinary incontinence.

Keywords: FDA warning; anterior vaginal wall; autologous sling; stress urinary incontinence.