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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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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. 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 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. 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).

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 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 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).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 The primary author and coordinating investigator, Aino Fianu Jonasson, takes responsibility for the integrity of the data. Conflicts of Interest Because these devices to reduce bladder leakage sit inside the vagina they are termed a “pessary” but they should not be confused with a traditonal pessary used for supporting Pelvic Organ Prolapse (POP). For more information about pessaries for prolapse read here Field Guide: bladder support pessaries to reduce stress urinary incontinence 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 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 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. 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. UsabilityMedian 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. Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. 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. 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! 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.

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.Bladder support pessaries are best for small leaks associated with movement. Or leaks when the bladder is under pressure from coughing, sneezing or laughing (stress urinary incontinence). 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. 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 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

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