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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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 full

In my clinical experience, these support pessaries work particularly well in certain situations. For example when the bladder has dropped only a little bit and the uterus is still well supported. Or, if exercises have created a good layer of muscles but you still need more bladder support to be active. How do internal bladder support pessaries reduce urinary leakage? The sample size calculation in the TVS2000 and TVS3000 study was based on the standard deviations for the average IIQ-7 score in the TVS1000 study. A study size of 25 subjects is required to detect a significant difference of at least 25% with a power of 80% and a significance level of 5%, expecting a standard deviation of 32%. 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!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. 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.*

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. 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. 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 ( ). Available in the UK at the moment are , Contrelle, Contiform, Efemia and Uresta. They vary in price chiefly relative to how many times they can be re-used. Contiform and Efemia are available on prescription. Contrelle Contiform efemia Uresta Would they suit you ? 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% ( ) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% ( ) 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. 1. IntroductionA 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 The secondary endpoints for the study were also met. 42% of the subjects in the TVS arm had >70% reduction in pad weight and the number of SUI episodes was reduced by 28%. 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. 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.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. Comparison of study design of the four postmarket surveillance studies. 2.3.3. Ethical Considerations

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 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. The study title is an Open Randomized Controlled Multicenter Clinical Investigation with an Intravaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care. 2.2.2. Study Population Basically, you might consider using a different carrier. Royal Mail have failed to deliver. I am chasing this up, but cannot review the item, because I haven't received it yet. Incontinence Impact Questionnaire (IIQ-7): IIQ-7 score was reduced with 10% for the TVS group and 12% for the control group. There was no statistical difference between the TVS group and the control group ( ).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. The number of SUI episodes at week 3 compared to baseline was reduced with a median of 28% ( n = 52, max-min, -95-150%) for the TVS group and 0% ( n = 23, max-min, -46-557%) for the control group with a value = 0.0019 in favour for the TVS group. 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? The Contiform Pessary looks like a plastic hollow tampon. The smaller circle supports the bladder tube (the urethra). The larger surface lies against the floor of the vagina, giving support to the bowel wall. They are made of a firm but flexible non-latex plastic. Each can be reused, with the guarantee up to 30 times. There is a “slit” that develops with wear to show you when the device needs changing. Use for longer if not worn all day. There is an optional ribbon to help with removal. The sample sizes of the TVS4000 and TVS5000 studies were not based on power calculations, since the primary endpoint was user satisfaction and they do not contain any hypothesis evaluations. It was estimated that a sample size of 20 women would represent a sufficient basis for evaluating user satisfaction during exercise. 2.3.2. Study Objectives