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Two‐year outcomes for the Altis ® adjustable single incision sling system for treatment of stress urinary incontinence
Author(s) -
Kocjancic Ervin,
Erickson Ty,
Tu LeMai,
Gheiler Edward,
Van Drie Douglas
Publication year - 2017
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23156
Subject(s) - medicine , urinary incontinence , sling (weapon) , distress , genitourinary system , adverse effect , stress incontinence , surgery , prospective cohort study , urinary system , urology , clinical psychology
Aims Evaluate the Altis single‐incision sling for treatment of female stress urinary incontinence through 24 months. Methods This was a prospective, multi‐center, industry‐sponsored (Coloplast Corp.), single‐arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6‐months. Device‐ and procedure‐related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory‐Short Form, Incontinence Impact Questionnaire‐Short Form, and Patient Global Impression of Improvement. Results Of the 113 women implanted, 94 remained at 24‐months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow‐up data at 24‐months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory ( P ‐value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores ( P ‐value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported “ very much better ” or “ much better ” on the Patient Global Impression of Improvement. No new device‐ or procedure‐related adverse events occurred between the 12 and 24 month visits. Conclusions The Altis single‐incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress‐predominant mixed urinary incontinence.