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These are devices that you can buy on the internet and then insert and remove yourself.They are designed to be worn all day but not all the time.These can be a surprisingly inexpensive & eco-friendly option, compared to disposable pads. Ideal if you know when you will leak and need to use the device only for intermittent pre-planned activities. 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. 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 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 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
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 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 ( ). If you have any specific questions or concerns about any medical matter, you should consult your doctor or healthcare provider as soon as possible.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. Incontinence is the unwanted and involuntary leakage of urine or stool. It affects an estimated 400 million people across the world. 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 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.
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%.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? 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. Investigational device, size 30 mm. Left: the design used in the clinical investigation; right: the design used in the postmarket studies. A = support rings, B = midsection, and C = handle. 2.2. Study Design of the Clinical Investigation TVS1000 2.2.1. Study Title
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. 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.Any information or guidance we provide is not a substitute for the consultation, diagnosis, and/or medical treatment of your doctor or healthcare provider. Have you done your pelvic floor exercises, improved your core, modified high impact and improved your fluid management? Still not quite resolved your bladder leakage? Then one of the bladder support pessaries may offer an alternative to surgery ( NICE Guideline NG123 2019). They have a similar mechanism of action (mechanical support of the urethra) to the TVT and colposuspension surgical procedures but no side effects or surgical risk.
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 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 World Continence Week (WCW) is a global initiative managed by WFIP, the World Federation for Incontinence and Pelvic Problems. Held for a week every year, WCW primarily aims to raise awareness of continence related issues around the globe. 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. 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?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 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.
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