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

Product Information

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 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).

So if you have had good success with one of the devices above this would be a natural progression to a potentially more environmentally friendly and overall less expensive option. If you have any specific questions or concerns about any medical matter, you should consult your doctor or healthcare provider as soon as possible. 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 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 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. 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 What these devices can’t do is change symptoms like urgency. If your bladder is irritated by caffeine, being too full, or you have an overactive bladder, you won’t see any improvement using one of these. Pelvic floor exercises DO help these symptoms because the pelvic floor contracting activates neurological messages which calm the bladder down. Unfortunately these devices can’t do that.

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. 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.

Urogenital Distress Inventory (UDI-6): UDI-6 score was reduced with 12% for the TVS group and 18% for the control group. No statistical difference between TVS group and control group was observed ( ). 3.4. Safety 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. 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. 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.Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. 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). 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 ? 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 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

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? All study participants were diagnosed with stress urinary incontinence, had normal voiding, were above 18 years, and leaked at least 10 g per 24 hours. Women with dominated urgency or neurogenic incontinence, hysterectomized, with a pronounced prolapse, pregnant, with a vaginal infection, or with a history of not being able to use tampons were excluded from the study. 2.2.3. Randomization 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 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 ProceduresNo 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. 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 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 clinical investigation was conducted at four clinics with Aino Fianu Jonasson, Dr, Md, PhD, urogynecology specialist at Karolinska University Hospital, as coordinating investigator. Participants were recruited via advertisements in newspapers and on Facebook. At the screening visit, a medical and surgical history, a physical examination (including gynecological examination), and a confirmation of the diagnosis of SUI were performed, followed by a confirmation of the inclusion/exclusion criteria. SUI was diagnosed by pad testing and measurement of residual urine after filling the bladder with 300 ml saline and provoking urine leakage by coughing, jumping, and rinsing hands in cold running water. A positive cough/jump test indicates stress incontinence while a positive rinsing test indicates urge incontinence. Calibrated scales were distributed to the participants for weighing pads. Baseline data was collected during the first week. During week 2, the women in the TVS group selected the device size and practiced how to use the device prior to the start of treatment at week 3. The control group continued with conventional treatment, i.e., using pads during weeks 2 and 3. For women who were menstruating, the study was interrupted, due to the fact that menstruation could affect the weight of the pads and consequently the study data. Specific instructions for re-entering the study were given to the subjects prior to start. The women used a diary to record their incontinent episodes, pad weight, physical activities, and general observations during the first three weeks of the study. They also performed a daily provocation test by coughing 10 times and jumping in place (or sit and stand if unable to jump) 20 times with a full bladder. At the weekly visits to the clinic, the women were asked QoL questions (IIQ-7, UDI-6, and EQ-5D-DL) and were asked to rate their experience of the device. After completing week 3, women in the control group were offered to use the device for two weeks. If they chose to do so, they switched over to a SoC-TVS group and went to a 5th visit to the clinic to answer questions regarding their experience. Both the TVS and the control group had a follow-up telephone call after 8 weeks. 2.2.8. Safety Monitoring