A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence
| Autor: | Ty Erickson, Mohamad Parva, Jan-Paul Roovers, Rebecca McCrery, Le Mai Tu, Craig Hanson, Edward Gheiler, Mitesh Parekh |
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| Přispěvatelé: | Obstetrics and Gynaecology, Amsterdam Reproduction & Development (AR&D), APH - Aging & Later Life |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Reoperation Canada medicine.medical_specialty Efficacy Visual analogue scale Urinary Incontinence Stress Urinary incontinence Single-incision midurethral sling surgery Sling (weapon) Cohort Studies 03 medical and health sciences Postoperative Complications 0302 clinical medicine Surveys and Questionnaires Postmarketing study Product Surveillance Postmarketing Minimal invasive Humans Medicine Adverse effect Prospective cohort study Aged Suburethral Slings 030219 obstetrics & reproductive medicine Stress urinary incontinence business.industry Genitourinary system Obstetrics and Gynecology Middle Aged United States Surgery Distress Treatment Outcome 030220 oncology & carcinogenesis Urologic Surgical Procedures Female Safety medicine.symptom business Follow-Up Studies Cohort study |
| Zdroj: | Journal of minimally invasive gynecology, 28(1), 93-99. Elsevier |
| ISSN: | 1553-4650 |
| DOI: | 10.1016/j.jmig.2020.04.014 |
| Popis: | Study Objective The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. Design Postmarket, prospective, multicenter, nonrandomized cohort design. Setting The study was performed at 23 hospitals in the United States and Canada. Patients Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). Interventions Altis SIS was compared with any Food and Drug Administration–cleared transobturator or retropubic sling. Measurements and Main Results Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire–Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire–Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. Conclusion At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings. |
| Databáze: | OpenAIRE |
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