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. 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 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? 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

Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. Absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement. 2.2.5. Secondary Endpoints 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. 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 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

Walk, run, jump, sneeze, laugh, lift!

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 ( ).

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. It is clear from the studies that even though most women found Efemia comfortable, it does not suit all. Further studies, evaluating comfort and user satisfaction on a larger group of women, over a longer time, could be useful as a guidance in further device development. Data Availability 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!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. Efemia effect on mean urine leakage (average daily pad weight), analysed on the full analysis set. 3.3. Secondary Outcome 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. Comparison of study design of the four postmarket surveillance studies. 2.3.3. Ethical Considerations 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 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 Overall success rate, defined as at least 70% reduction in pad weight from run-in to the final week (week 3) Reduction of SUI episodes Reduced incontinence impact on QoL, measured using the validated patient reported outcome questionnaires EQ-5D-5 L, IIQ-7, and UDI-6 2.2.6. Study Size and Statistical Analysis 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. 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.

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. 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 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 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.

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.* 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. Incontinence is the unwanted and involuntary leakage of urine or stool. It affects an estimated 400 million people across the world.The primary author and coordinating investigator, Aino Fianu Jonasson, takes responsibility for the integrity of the data. Conflicts of Interest 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). 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?