A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies

Author:

Jonasson Aino Fianu1ORCID,Bryder Karin2ORCID,Sthengel Elisabeth2ORCID

Affiliation:

1. Division of Obstetrics and Gynaecology, Karolinska University Hospital, Huddinge, 141 86, Stockholm, Sweden

2. Invent Medic Sweden AB, Medicon Village, 223 81, Lund, Sweden

Abstract

A multicenter, randomized, controlled clinical trial and four postmarket user acceptance investigations were carried out to document the safety, performance, and user acceptance of Efemia Bladder Support, a novel vaginal inlay for the temporary reduction of stress urinary incontinence (SUI). The clinical investigation enrolled 97 women diagnosed with SUI, randomized 3 : 1 to either treatment or standard care (control). The primary endpoint was reduction of urine leakage, measured as change in pad weight baseline week compared with treatment week. Secondary endpoints were treatment success, calculated as the percentage of subjects with >70% reduction in pad weight, reduction in incontinence episodes, and quality of life (QoL). 75 women (77%) completed the clinical investigation. No serious adverse events occurred. The treatment group reached a 55% ( p < 0.001 ) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% ( p < 0.001 ) mean reduction of leakage. No significant effect on QoL could be observed. 51% of the women answered “yes” to the question if they would use the device to reduce SUI. The user acceptance of the device was further investigated in four postmarket studies, using an improved device design with a slimmer centerpiece and a thinner handle, while keeping the effect achieving parts of the device unchanged. An average of 74% of the 102 participants in the postmarket studies reported that they were likely to continue using Efemia. The highest user satisfaction was seen in the two studies evaluating the use of Efemia during exercise, where 83% and 88% of the women were likely to continue using Efemia. It can be concluded that Efemia is a safe, well-tolerated, and effective alternative for reducing SUI, both in everyday life and during physical exercise.

Funder

Invent Medic

Publisher

Hindawi Limited

Subject

Urology,Obstetrics and Gynaecology

Cited by 3 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Sports Medicine and the Pelvic Floor;Current Sports Medicine Reports;2023-03

2. Current State of Non-surgical Devices for Female Stress Urinary Incontinence;Current Urology Reports;2022-08-23

3. Compliance with Uresta (CURE) study; a 12 month follow-up of 40 women;International Urogynecology Journal;2022-05-27

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