Mid‐term safety and efficacy of the ALTIS^® single‐incision sling for female stress urinary incontinence: less mesh, same results

Abstract

Objective To analyse the mid‐term safety and efficacy of the ALTIS® single‐incision sling (Coloplast Corp., Minneapolis, MN, USA) for female stress urinary incontinence (SUI). Patients and Methods We conducted a prospective, single‐arm, unsponsored, observational single‐centre trial in a cohort of patients undergoing SUI surgery with the ALTIS procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index (BMI) was categorised according to World Health Organization classification. Valsalva leak‐point pressure (VLPP) was categorised in three groups: <60, 60–90 and >90 cmH2O. Patients were evaluated postoperatively at 1, 6, 12 and 24 months with physical examination, International Consultation on Incontinence Questionnaire Short Form (ICIQ‐SF), and satisfaction visual scale (SVS; score 0–10). Adverse events were assessed at each visit. Multivariate analysis for risk factors of surgery failure was performed. Results We recruited 110 women, with a mean (SD) follow‐up of 22.34 (10.34) months. Regarding efficacy, 91 patients (82.7%) were objectively cured and 97 (88.2%) were subjectively cured. Regarding VLPP and BMI, no differences were seen between groups (P > 0.05). There was a ~20% decrease in urge UI (P = 0.04). No variable showed to be an independent risk factor for ALTIS failure (P > 0.05). Overall, nearly 96% of the women reported 9 or 10 points on the SVS. A total of 24 patients (21.8%) had some kind of complication. No mesh erosion was reported in any patient. Conclusions The ALTIS sling demonstrated to be an effective and safe procedure for SUI in the mid‐term setting. Objective and subjective cure rates are at least comparable to ‘gold standard’ procedures with a minimal rate of self‐limiting non‐surgical complications.

Six-year follow-up in patients with urinary stress incontinence treated with Altis® single-incision sling: a prospective single-center study

“…Most of the scientific publications are retrospective observational studies, 13,15 and prospective single-center 16,17 or multicenter. 18 Our work is a prospective observational single-center study with a 6-year follow-up.…”

“…18 Our work is a prospective observational single-center study with a 6-year follow-up. The literature reviewed reports follow-ups at 1year, 13,16,19,20 2years 17,18 and 3years. 15 Our work includes women with a history of pure SUI and MUI with a predominance of stress incontinence, a positive cough test in consultation with urethral hypermobility, and failed or unwanted previous conservative treatment.…”

The Outcome of a Single-Incision Sling versus Trans-Obturator Sling in Overweight and Obese Women with Stress Urinary Incontinence at 3-Year Follow-Up

“…The objective and subjective cure rates were promising in both the obese and non-obese groups without significant differences. Morán et al conducted a prospective, single-arm study with a mean follow-up period of 22.3 months and reported objective and subjective cures of 83% and 88% irrespective of the BMI [7]. Oliveira et al conducted a prospective, single-arm study with a mean follow-up period of 12 months and reported postoperative improvement rates in of 94% and 90% in women with and without obesity, respectively [15].…”

“…Although the relationship between obesity and SUI has been well documented, relatively few studies have investigated the safety and efficacy of surgical treatments among overweight and obese women. A mid-urethral sling is currently the most effective treatment for incontinence [7]. The first mid-urethral sling, tension-free vaginal tape, was developed by Ulmsten in 1996 with promising long-term results [8].…”

“…Subsequently, the trans-obturator sling (TOS) was launched in 2001 to reduce the risk of complications and was reported to have similar efficacy [8]. In 2006, the single-incision sling (SIS), a less invasive procedure, was developed as an alternative procedure to reduce inguinal pain after TOS [7].…”