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 cmH2 O. 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.
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 cmH2 O. 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.