To substantiate data on objective and subjective effectiveness and clinical benefits-including health-related quality of life and patient satisfaction-following treatment with a single-incision mini-sling (SIMS) in real-life practice.
Women with predominant stress urinary incontinence (SUI) who were candidates for surgical treatment were prospectively enrolled in a multicenter, single-arm clinical trial and implanted with Altis (Coloplast Corp, Minneapolis, MN) SIMS under general anesthesia or sedation. The primary composite endpoint was the 12-mo cure rate, defined as a negative cough stress test (CST) and a "no" response to question 3 of the Urological Distress Inventory (UDI)-6 questionnaire (ie, no SUI symptoms). Cure rate, self-reported symptoms, quality of life, impression of improvement, satisfaction and adverse events were reported at each time point until 36 mo.
Cure rate was 75.7% (81/107 evaluable patients) at 12 mo, mainly explained by persistent SUI in subjective patient questionnaires, whereas more than 90% of patients had a negative CST, and used no more pads or a security pad. The mean 24 h pad weight declined significantly at 12 mo compared to baseline (41.2 ± 77.2 g, to 1.2 ± 4.7 g, p < 0.001). At 36 mo (after a 36% dropout rate), all scores and questionnaires were significantly improved, with a high level of improvement and satisfaction. Complication rates were low and similar to those reported for other midurethral slings.
Our study contributes to the growing body of data on Altis's safety and effectiveness in SUI.
European urology focus. 2026 Apr 01 [Epub ahead of print]
Jean-Nicolas Cornu, Hugo van Eijndhoven, Gery Lamblin, Ursula Peschers, Giuseppe Ettore, Zaida Furio Bernardo, Gilles Karsenty, Carmen Gonzalez Enguita, Christian Saussine, Laurent Wagner, Martine Dehez, Philippe Grise, Brigitte Fatton
Service d'Urologie, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France. Electronic address: ., Isala Women and Children's Hospital, Zwolle, The Netherlands., Hôpital Femme Mère Enfant, Service Gynécologie-Obstétrique, Bron, France., Dept. of Obstetrics and Gynecology Krankenhaus Neuwerk Mönchengladbach, Germany., Ospedale "Garibaldi-Nesima" Ostetricia e Ginecologia, Catania, Italy., Hospital Universitario La Ribera, Ginecología Departamento, Alzira-Valencia, Spain., AP-HM Hôpital de la Conception, Urologie et Transplantation Rénale, Marseille, France., Fundación Jiménez Díaz, Madrid, Spain., Service de Chirurgie Urologique, Nouvel Hôpital Civil / NHC, Strasbourg, France., CHU Carémeau, Service d'Urologie-Andrologie, Nîmes, France., Coloplast Manufacturing France, 92357 Le Plessis-Robinson, France., Service d'Urologie, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France., CHU Carémeau, Service de Gynécologie-Obstétrique, Nîmes, France.