Efemia Bladder Support Device for Women with Stress Urinary Incontinence, Vaginal Tampon for Sports, Comfortable & Discreet, Reduces/Prevents Leaks 16hrs/Day, Up to 3 Months - 30 mm Diameter

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There are several treatment options for SUI available. In clinical practice, it is the convention that nonsurgical therapies are tried first because they usually carry the least risk of harm. Containment devices (absorbent pads, urinary catheters, and intravaginal devices) play an important role, especially for individuals who prefer to avoid the risks of interventional treatments, or in whom active treatment is impossible for any reason. [ 5]. Insertion of a synthetic sling to give support to the midurethra is currently the first in line recommended surgical approach [ 5, 6]. However, as more women are treated, concerns of the safety of the surgery have been raised. In a data analysis of incontinence surgery registered in The Swedish National Registry for Gynecologic Surgery (GynOP), presented at the ICS 2019 conference, S. Zacharias et al. reported that, out of 4,160 Swedish women that went through incontinence surgery during 2017, 681 women (16%) responded that they either had a complication, were worse off in their incontinence than before, or were unhappy with the results. The most common problems were urinating problems, pain, infection, and rupture/erosion of the tape in the vagina [ 7]. It is clear from this data that there is a need for effective nonsurgical alternatives for treatment or alleviation of SUI. 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 most common screening failure was <10 g urine leakage during 24 h ( n = 25), followed by prolapse reaching hymen when coughing ( n = 12). Recruitment started in Feb 2017 and the study was completed in Jan 2018. The women were randomized 3 : 1 to either use the device or standard care (SoC).

Uresta, designed and manufactured in Canada, joins this family of internal support devices with the unique selling point that it is fully reuseable for one year. If you think you may be suffering from any medical condition, you should seek immediate medical attention from your healthcare provider. Do not delay seeking medical advice, disregard medical advice or discontinue medical treatment because of information or guidance we provide you with. The postmarket studies, using the current version of the device, showed a high user satisfaction. This was particularly noteworthy in the two studies where Efemia was used during exercise, where >80% of the women were likely to continue to use Efemia and >90% were likely to recommend Efemia to a friend. However, it is important to note that the evaluation of Efemia during exercise is based on a total of 21 women, using Efemia during cross-fit training and weightlifting. Studies, involving other sports and more women, would therefore be useful for evaluating the use of Efemia by physically active women. Some of the marketing blurbs list “strengthen your pelvic floor” as a benefit of using their pessary device. This is only true in the loosest meaning. While they are in place, by artificially re-inforcing the vagina wall, I suppose you could claim that is “strengthening” the pelvic floor action – but they are in no way making any change to the muscle. Only exercise can change the composition and activity of the muscles or surgery the non-muscular elements. When you take the device out the structural situation remains the same.However, these devices definitely offer an alternative to surgery. Or a Buy Some Time option if you need to complete your family or are undecided about a bigger procedure. Living life to the fullThe 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 impact of incontinence on the daily life was measured in TVS2000 and TVS3000 using the validated Incontinence Impact Questionnaire IIQ-7, where the women were asked to grade the impact of their incontinence in 7 areas of everyday life before and after having tried Efemia for 4 weeks. A grading of 0–3 was used, where 0 = not at all, 1 = slightly, 2 = moderately, and 3 = greatly. There was a significant improvement in IIQ-7 scores with a 27% mean decrease in TVS2000 ( ) and a 29% mean decrease in TVS3000 ( ). 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. The quality of life endpoints in TVS1000 were not met. No clinically significant decrease in the IIQ-7 score, compared to controls, could be detected after 2-week use of the device, while there was a modest but significant decrease of the IIQ-7 score in the two user satisfaction studies TVS2000 and TVS3000, with 27% and 29% reduction, respectively. The published validation of the Swedish form of the IIQ-7 questionnaire reported a strong-to-moderate correlation with treatment satisfaction and reduction of the IIQ-7 score [ 15]. It was therefore surprising to note that there was no significant correlation between any of the treatment satisfaction variables (willingness to continue using or recommending Efemia), and reduction of IIQ-7 scores in the present investigations. In fact, 6 of the 8 women in the TVS3000 study and 5 of the 7 women in the TVS2000 study, with an increase or no change in the IIQ-7 score after treatment, reported that they were likely to continue using Efemia. It is difficult to understand why anyone will want to continue to use Efemia if it has no effect or even worsens the impact of incontinence on their daily life, as measured with IIQ-7. An explanation might be that women with mild SUI cannot relate to the IIQ-7 questions because most of them are likely to use protective pads in situations where they expect to leak. Therefore, their incontinence has very little impact on their ability to perform daily activities. As one of the women comments, “I think the IIQ-7 questions are wrongly designed. Incontinence is unpleasant but it does not affect my ability to do things.” The inadequacy of IIQ-7 for quantifying the objective severity of SUI is confirmed in the publication by Franco et al. where they found no correlation between reduction in urine leakage (1-hour pad weight) and change in IIQ-7 score [ 16]. In future studies, the validated ICQ-SF questionnaire might be better suited for assessing incontinence impact on the quality of life in relation to the use of Efemia. However, it can be clearly concluded that the treatment satisfaction was high and that Efemia facilitated the daily lives of the study participants.

Overall success rate, defined as at least 70% reduction in pad weight from the run-in week to the final week (week 3): 42% of the subjects in the TVS arm and 4% of the subjects in the control arm had more than 70% reduction in pad weight with a value = 0.0008 in favour for the TVS group. These are devices that you can buy on the internet and then insert and remove yourself.They are designed to be worn all day but not all the time.These can be a surprisingly inexpensive & eco-friendly option, compared to disposable pads. Ideal if you know when you will leak and need to use the device only for intermittent pre-planned activities. We understand what it’s like to deal with this condition. You feel limited in what you can do, and feel embarrassed that others will be able to tell. But with the help of Wearever’s discreet incontinence underwear for women you can start to reinvent yourself.The clinical investigation TVS1000 confirmed that Efemia Bladder Support is safe and achieves its primary performance objective to reduce involuntary urine leakage with a 55% ( ) mean reduction of leakage compared to the control group. The subanalysis of leakage during the daily provocation tests showed a 67% ( ) mean reduction of leakage. 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