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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. Randomization 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). 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 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 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. 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? 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 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. 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. IntroductionNo 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 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.
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. 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. 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. 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. 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
2. Insertion
The impact of incontinence on the daily life was measured in TVS2000 and TVS3000 using the validated Incontinence Impact Questionnaire IIQ-7, where the women were asked to grade the impact of their incontinence in 7 areas of everyday life before and after having tried Efemia for 4 weeks. A grading of 0–3 was used, where 0 = not at all, 1 = slightly, 2 = moderately, and 3 = greatly. There was a significant improvement in IIQ-7 scores with a 27% mean decrease in TVS2000 ( ) and a 29% mean decrease in TVS3000 ( ).
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