Three-year follow-up in patients with urinary stress incontinence treated with Altis® single-incision sling.

Abstract

Background: The purpose of the study is to report three years follow-up of single incision slings for the treatment of stress urinary incontinence (SUI). The main outcomes are to evaluate the efficacy of the device and to assess safety, adverse events, quality of life, demographic features of treated women and prognostic factors for SUI.

Methods: We performed a retrospective, double-center, single-arm study. Data were collected by medical records and a telephone interview 3 years after the implant of the mini-sling. Complication rate, subjective efficacy and degree of satisfaction were investigated.

Results: Fifty-four patients were treated between March 2015 and March 2017, of which 47 answered the survey. Forty-one of 47 procedures (87.2%) were considered effective. Among more relevant complications, there was one case of extrusion of mesh and three cases of new onset of urinary disfunction, of which two cases of urgency urinary incontinence (UUI) and one case of de-novo SUI. Most complications were solved within few days after the procedure. Concerning the subjective impression of improvement, investigated by using the Patient Global Impression of Improvement (PGI-I) questionnaires, 41 patients reported subjective satisfaction, three reported no change in quality of life and three patients had worsening of symptoms.

Conclusions: The procedure was safe and effective for the treatment of SUI but more data are needed to confirm our preliminary results.