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 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!

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 Data from prematurely withdrawn subjects was included in the analysis as far as possible.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

What women say about Efemia

Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. 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 size calculation in the TVS2000 and TVS3000 study was based on the standard deviations for the average IIQ-7 score in the TVS1000 study. A study size of 25 subjects is required to detect a significant difference of at least 25% with a power of 80% and a significance level of 5%, expecting a standard deviation of 32%. 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.* 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).

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 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 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. The quality of life endpoints in TVS1000 were not met. No clinically significant decrease in the IIQ-7 score, compared to controls, could be detected after 2-week use of the device, while there was a modest but significant decrease of the IIQ-7 score in the two user satisfaction studies TVS2000 and TVS3000, with 27% and 29% reduction, respectively. The published validation of the Swedish form of the IIQ-7 questionnaire reported a strong-to-moderate correlation with treatment satisfaction and reduction of the IIQ-7 score [ 15]. It was therefore surprising to note that there was no significant correlation between any of the treatment satisfaction variables (willingness to continue using or recommending Efemia), and reduction of IIQ-7 scores in the present investigations. In fact, 6 of the 8 women in the TVS3000 study and 5 of the 7 women in the TVS2000 study, with an increase or no change in the IIQ-7 score after treatment, reported that they were likely to continue using Efemia. It is difficult to understand why anyone will want to continue to use Efemia if it has no effect or even worsens the impact of incontinence on their daily life, as measured with IIQ-7. An explanation might be that women with mild SUI cannot relate to the IIQ-7 questions because most of them are likely to use protective pads in situations where they expect to leak. Therefore, their incontinence has very little impact on their ability to perform daily activities. As one of the women comments, “I think the IIQ-7 questions are wrongly designed. Incontinence is unpleasant but it does not affect my ability to do things.” The inadequacy of IIQ-7 for quantifying the objective severity of SUI is confirmed in the publication by Franco et al. where they found no correlation between reduction in urine leakage (1-hour pad weight) and change in IIQ-7 score [ 16]. In future studies, the validated ICQ-SF questionnaire might be better suited for assessing incontinence impact on the quality of life in relation to the use of Efemia. However, it can be clearly concluded that the treatment satisfaction was high and that Efemia facilitated the daily lives of the study participants. Efemia effect on mean urine leakage (average daily pad weight), analysed on the full analysis set. 3.3. Secondary OutcomeAre 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?