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A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence.
J Minim Invasive Gynecol. 2021 01; 28(1):93-99.JM

Abstract

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.

Authors+Show Affiliations

Department of Gynaecology, Rosemark Women Care Specialists, Idaho Falls, Idaho (Dr. Erickson).Department of Gynaecology, Amsterdam UMC, Amsterdam, Netherlands (Dr. Roovers). Electronic address: j.p.roovers@amsterdamumc.nl.Department of Gynaecology, Nova Southeastern University/Urological Research Network LLC, Hialeah, Florida (Dr. Gheiler).Department of Gynaecology, Genesis Healthcare, Zanesville, Ohio (Dr. Parekh).Department of Gynaecology, The Group for Women, Tidewater Clinical Research, Norfolk, Virginia (Dr. Parva).Department of Gynaecology, Women's Health Advantage, Fort Wayne, Indiana (Dr. Hanson).Department of Gynaecology, Adult and Pediatric Urology and Urogynecology, Omaha, Nebraska (Dr. McCrery).Department of Surgery, Division of Urology, Hospital Center, University of Sherbrooke, Sherbrooke, Quebec, Canada (Dr. Tu).

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32320798

Citation

Erickson, Ty, et al. "A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence." Journal of Minimally Invasive Gynecology, vol. 28, no. 1, 2021, pp. 93-99.
Erickson T, Roovers JP, Gheiler E, et al. A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. J Minim Invasive Gynecol. 2021;28(1):93-99.
Erickson, T., Roovers, J. P., Gheiler, E., Parekh, M., Parva, M., Hanson, C., McCrery, R., & Tu, L. M. (2021). A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. Journal of Minimally Invasive Gynecology, 28(1), 93-99. https://doi.org/10.1016/j.jmig.2020.04.014
Erickson T, et al. A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. J Minim Invasive Gynecol. 2021;28(1):93-99. PubMed PMID: 32320798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. AU - Erickson,Ty, AU - Roovers,Jan-Paul, AU - Gheiler,Edward, AU - Parekh,Mitesh, AU - Parva,Mohamad, AU - Hanson,Craig, AU - McCrery,Rebecca, AU - Tu,Le Mai, Y1 - 2020/04/19/ PY - 2020/02/25/received PY - 2020/04/07/revised PY - 2020/04/08/accepted PY - 2020/4/23/pubmed PY - 2021/4/13/medline PY - 2020/4/23/entrez KW - Efficacy KW - Minimal invasive KW - Postmarketing study KW - Safety KW - Single-incision midurethral sling surgery KW - Stress urinary incontinence KW - Surgery SP - 93 EP - 99 JF - Journal of minimally invasive gynecology JO - J Minim Invasive Gynecol VL - 28 IS - 1 N2 - 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. SN - 1553-4669 UR - https://www.unboundmedicine.com/medline/citation/32320798/A_Multicenter_Prospective_Study_Evaluating_Efficacy_and_Safety_of_a_Single_incision_Sling_Procedure_for_Stress_Urinary_Incontinence_ DB - PRIME DP - Unbound Medicine ER -