"EASY Study": A European, Prospective, Postmarket, Single-arm Study of Altis Single-incision Mini-sling for Female...

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.