World Continence Week (WCW) is a global initiative managed by WFIP, the World Federation for Incontinence and Pelvic Problems. Held for a week every year, WCW primarily aims to raise awareness of continence related issues around the globe.

The aim was to enroll 96 female study subjects. A study size of 96 patients was calculated using a standard deviation of 9 g, a power of 90%, a significance level of 5%, and a 20% dropout rate. A mean leakage reduction of 13 g was assumed for the active group and 5 g for the control group (MIREDIF = 8 g). The full analysis set, defined as randomized subjects with at least one test measurement after randomization (FAS), was used for safety primary and secondary efficacy endpoints. A subanalysis, involving only leakage during provocation testing, was also planned. Center and treatment were used as covariates in the analysis of the primary variable. Hypothesis was tested using a two-sided Student’s t-test with a 5% significance level. No adjustments for multiplicity were performed. Outliers were not excluded. Data from prematurely withdrawn subjects was included in the analysis as far as possible. No imputation of missing data was performed. 2.2.7. Study Procedures

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 ( ). Likelihood to recommend (graph (a)) and mean change in the IIQ-7 score (graph (b)), plotted against facilitation of everyday life, TVS3000 ( n = 30). 5. Discussion A total of 92 women were exposed to the device for two weeks during the investigation. No device-related serious adverse effects occurred. 32 of the 92 subjects using the device reported device-related adverse effects (45 episodes). The most frequent adverse device effect was discomfort (30), followed by bleeding (4), vaginal discharge (4), contusion (4), itching (2), and candidiasis (1). All adverse effects were resolved when TVS use was reduced, except for the single incident of candidiasis that needed medical intervention. 3.5. Usability Absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement. 2.2.5. Secondary Endpoints

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). Following years of Problems my urogynaecology physio recommended Efemia. I had put on a little weight due to not being able to exercise without embarrassment & life was becoming awful. I have always been so active and have a physical job, so it was so upsetting. I tried the item and instantly have found it to be a godsend! You must not rely on any information or guidance we provide you with as an alternative to medical advice from your doctor or healthcare provide and we expressly disclaim all responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered by you or any third party as a result of your reliance on any information or guidance we provide you with.

Why use Efemia bladder support?

If urgency or frequency symptoms are your bother – then you need to practice “endurance/holding” pelvic floor exercises (see more in the Pelvic Floor School) and have also read of the article “How much should you drink in day and when should you have a wee?” for more impact on these problems. Can I leave it in to wee? What about during my period? Overall success rate, defined as at least 70% reduction in pad weight from run-in to the final week (week 3) Reduction of SUI episodes Reduced incontinence impact on QoL, measured using the validated patient reported outcome questionnaires EQ-5D-5 L, IIQ-7, and UDI-6 2.2.6. Study Size and Statistical Analysis My fight now is to get Efemia on prescription. On all internet searches it states that it is available in the UK on NHS prescription. However, my Doctor called me yesterday saying that it is not available on prescription as it is not recommended by NICE. It seems I am getting contradictory information. I’d be grateful to hear of anyone else in the UK getting it on prescription. AGHealth, distributors of innovative obstetric and gynaecology devices, are proud to announce that Efemia Bladder Support is now on NHS Prescription, helping improve the lives of women affected by Stress Urinary Incontinence (SUI).

No serious adverse device effects occurred. The most commonly reported adverse device effect in the TVS1000 investigation was discomfort (30 reports). Since the TVS1000 investigation, there has been a design change resulting in a lighter and more appealing product. It is therefore interesting to compare the device comfort in the TVS1000 investigation where the old design was used with the TVS2000 study in which the current design was used. In the TVS1000 investigation, 33% of the women considered the device to be uncomfortable while discomfort was experienced by only 7% of the women in the TVS2000 study, where the current device design was used. 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. 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. Yes, they are all designed to be left in when you have a wee or bowel movement. The pressure of the bladder squeezing is enough to push the urine past the supported area when you need to. 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.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. It is clear from the studies that even though most women found Efemia comfortable, it does not suit all. Further studies, evaluating comfort and user satisfaction on a larger group of women, over a longer time, could be useful as a guidance in further device development. Data Availability Incontinence is the unwanted and involuntary leakage of urine or stool. It affects an estimated 400 million people across the world. 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.