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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However, if you are not worrying about leaking,you will fee more confident to exercise. This is a Good Thing for your overall health, wellbeing and mood. Comparison of study design of the four postmarket surveillance studies. 2.3.3. Ethical Considerations Subjects were carefully monitored for the occurrence of adverse events (AE) during the investigation period from randomization to the completion of follow-up. The clinical investigators collected AE information using nonleading questions. Events directly observed or spontaneously volunteered by subjects were also recorded. 2.2.9. Ethical Considerations

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. RandomizationA 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 Incontinence is the unwanted and involuntary leakage of urine or stool. It affects an estimated 400 million people across the world. 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.*

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 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. 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. 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. 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.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. 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). 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 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 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.

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 PopulationYou 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. 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 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. Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. 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