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! 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. 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?

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

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. 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. 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. 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. Introduction 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. SafetyOverall 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.

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 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 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. Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. Are a visual person?Imagine a running hose pipe, lying on soft grass. When you lay your foot on the pipe you may slow the flow of water. But you may not be able to stop it completely. However, if you lay your hosepipe on a firmer surface, like a garden path, when you press down on the hosepipe the water flow stops. A toned pelvic floor should act like that firm path. But if yours isn’t up to scratch a pessary could do that job instead. What type of urinary leakage will they help?The aim of the present clinical investigation and postmarket studies was to evaluate the safety, efficacy, and usabillity of Efemia. 2. Materials and Methods 2.1. Investigational Device In connection with PeniMasterPRO the rod pulling force generator allows for elongating the penis in an axially symmetrical manner without abutment far from the penis (attachment location). This means that no other bodily part or piece of clothing is required to generate the pulling force on the glans chamber and that the pulling force is nearly the same at all positions of the penis. By using the rod expander the penis can be elongated either in an upwards or a downwards direction or diagonally – and this has proven to be unobtrusive, even under normal clothing. Thus, many activities of day-to-day life can be implemented without any problems.