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

BACKGROUND AND

OBJECTIVE

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.

METHODS

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.

KEY FINDINGS AND LIMITATIONS: 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.

CONCLUSION AND CLINICAL IMPLICATIONS: Our study contributes to the growing body of data on Altis's safety and effectiveness in SUI.