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

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.

Compliance with Uresta (CURE) study; a 12 month follow-up of 40 women

“…Research on incontinence devices is limited and has typically focussed on clinical parameters such as pad tests, rather than long-term compliance and patient reported outcomes. Recent studies on Contiform [ 13 ], Diveen [ 14 ] and Efemia [ 15 ] followed up participants for just 4 to 6 weeks. A study on Incostress [ 16 ] attempted to follow up participants at 3 and 6 months but struggled to do so, with a third of participants lost to follow-up.…”

“…We excluded women who reported significant urgency on the ICIQ-FLUTS questionnaire. Other studies have excluded patients with significant urgency based on clinical history [ 15 ] or with urodynamic studies [ 7 , 18 ]. We excluded women with a BMI >30 kg/m 2 as obesity is a risk factor for SUI and we felt it reasonable to assume obesity may be a risk factor for incontinence device failure.…”

“…By comparison, of the 46 women recruited to our study, one was withdrawn due to difficulty with removal. In a recent study on Efemia, 85% of participants rated the device as ‘easy’ or ‘very easy’ to insert or remove although follow-up was just 6 weeks [ 15 ]. The potential relationship between ease of use and long-term compliance with incontinence devices should be assessed with comparative studies.…”

“…In our study cohort, 85% had previously tried PFMT and 25% had previously tried an incontinence device. A previous study has listed PFMT as an exclusion criteria [ 14 ] whilst other studies have not mentioned PFMT at all [ 8 , 15 , 16 ]. We would advocate incontinence devices should be integrated alongside, or following, a course of PFMT rather than considered a separate treatment option.…”

Sports Medicine and the Pelvic Floor

“…In these circumstances, there are several adjuncts to PFM training which may offer relief of symptoms such as silicone pessaries, urethral support devices, and compression garments. Pessaries offer support to the tissues supporting the internal pelvic organs, which may be lax and predispose the athlete to symptoms, while urethral support devices specifically target support to the urethra (96)(97)(98). Compression garments targeting the lumbopelvic region are a relatively new concept but may be able to optimize PFM function (99)(100)(101)(102).…”