Bladder support pessaries are best for small leaks associated with movement. Or leaks when the bladder is under pressure from coughing, sneezing or laughing (stress urinary incontinence).

A clinical trial of 32 women found that of those still using it at 2 weeks (21 women out of the original 32), 76% of them (16) were still using it at their 12 month visit.*The usability analysis included all 72 women that had been exposed to the device at any time during the investigation and answered the usability questions. 85% of the women rated the device as easy or very easy to insert or remove. 51% answered “yes” to the question if they would use the device to reduce SUI, and 75% of them would recommend the device to a friend. 58% found the device to be comfortable (acceptable or perfectly acceptable), 13% were neutral, and 29% found it to be unacceptable. 4. Results of Postmarket Surveillance Studies: TVS2000, TVS3000, TVS4000, and TVS5000 The studies were designed and performed by adhering to the ICC/ESOMAR international code of marketing and social research [ 14]. In addition, ethical approval was obtained for the TVS2000 study because it included participants from the previous clinical investigation TVS1000 (EC ref: EPN Lund, Dnr: 2018/959). 3. Results and Discussion 3.1. Results of TVS1000 Clinical Investigation Median gradings of the questions: on a scale of 0–10, how likely are you to continue using Efemia or to recommend Efemia to a friend? Error bars = 95% CI.

For women diagnosed with SUI, Efemia can be an effective and safe alternative, either temporarily, while waiting for surgery, or to be able to avoid surgery altogether. Furthermore, since Efemia is available “over-the-counter,” it might improve the daily lives of active women experiencing urine leakage during physical exercise, who might not see themselves as generally incontinent and therefore do not seek medical help. A weakness of the TVS3000 investigation is that the device usage was surprisingly low, such that most of the responders had used Efemia only a few times during the 4-week trial period. The reason for this is not clear. It could be either that the participants had very mild incontinence and only experienced urine leakage a few times during the 4-week trial period or that they were not fully dedicated to the study, but rather participated to collect loyalty points from Aller Media. 6. Conclusion Because these devices to reduce bladder leakage sit inside the vagina they are termed a “pessary” but they should not be confused with a traditonal pessary used for supporting Pelvic Organ Prolapse (POP). For more information about pessaries for prolapse read here Field Guide: bladder support pessaries to reduce stress urinary incontinence Have you done your pelvic floor exercises, improved your core, modified high impact and improved your fluid management? Still not quite resolved your bladder leakage? Then one of the bladder support pessaries may offer an alternative to surgery ( NICE Guideline NG123 2019). They have a similar mechanism of action (mechanical support of the urethra) to the TVT and colposuspension surgical procedures but no side effects or surgical risk. Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider.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. Comparison of study design of the four postmarket surveillance studies. 2.3.3. Ethical Considerations