BTL Emsella for Stress Urinary Incontinence
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: William Beaumont Hospitals
Must be taking: Anticholinergics, Tricyclic antidepressants
Disqualifiers: Morbid obesity, Pulmonary insufficiency, Neurogenic incontinence, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial will test if the Emsella chair, which uses electromagnetic waves to strengthen pelvic muscles, is effective for people with stress urinary incontinence. The goal is to see if this treatment can reduce urine leakage during activities like exercise or laughing. This new technology is used for pelvic muscle strengthening for the treatment of stress urinary incontinence.
Will I have to stop taking my current medications?
You won't have to stop taking your current medications, but you must keep the dose stable if they affect urinary function. You also can't start any new treatments during the trial.
What data supports the effectiveness of the treatment BTL Emsella for stress urinary incontinence?
Research suggests that extracorporeal magnetic stimulation (EMS), which is similar to the technology used in the BTL Emsella chair, is a non-invasive, effective, and safe treatment for stress urinary incontinence. This indicates that the BTL Emsella chair, which uses high-intensity focused electromagnetic (HIFEM) technology, may also be effective for this condition.12345
Is BTL Emsella safe for treating stress urinary incontinence?
How does the BTL Emsella treatment for stress urinary incontinence differ from other treatments?
BTL Emsella is unique because it uses High-Intensity Focused Electromagnetic (HIFEM) technology to stimulate pelvic floor muscles, which is a non-invasive approach compared to surgical options like slings or inlays. This treatment allows patients to remain fully clothed during sessions, making it more convenient and less invasive than traditional surgical methods.158910
Eligibility Criteria
This trial is for men and women aged 18-80 with stress urinary incontinence, who can consent to the study's requirements. Participants must not start new treatments or change current medication doses during the study. Women using bladder support devices or of childbearing age must follow specific guidelines, while men should be post-prostatectomy.Inclusion Criteria
You have a cough or bladder problem that shows up during a test.
I agree to not use any bladder support devices during the study.
I agree to keep my bladder-related medication doses constant during the study.
See 5 more
Exclusion Criteria
I am not pregnant and do not plan to become pregnant during the study.
My BMI is 40 or higher.
I have a piercing between my waist and knees and won't remove it for treatment.
See 17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive electromagnetic perineal stimulation using the Emsella chair or sham treatment, with 8 sessions over 4 weeks
4 weeks
8 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of urinary incontinence and sexual function
8 weeks
Treatment Details
Interventions
- BTL Emsella (Electromagnetic Technology)
- Sham BTL Emsella (Behavioural Intervention)
Trial OverviewThe trial tests the Emsella chair against a sham (fake treatment) to see if electromagnetic technology helps treat involuntary urine leakage caused by pressure from activities like coughing or laughing.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.
Group II: Emsella Sham TreatmentPlacebo Group1 Intervention
Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\<10% power).
BTL Emsella is already approved in United States for the following indications:
🇺🇸 Approved in United States as BTL Emsella Chair for:
- Stress Urinary Incontinence (SUI) in men and women
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beaumont Hospital-Royal OakRoyal Oak, MI
Loading ...
Who Is Running the Clinical Trial?
William Beaumont HospitalsLead Sponsor
References
[Treatment of female recurrent or not stress urinary incontinence with intrinsic sphincter deficiency: Sub-urethral retropubic adjustable sling (Remeex)]. [2022]Recommendations for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD) or recurrent, are complex. They accept the use of sub-urethral slings (BSU), if unsuccessful the artificial urinary sphincter. The objective was to report the results in terms of continence and morbidity of the Remeex® Adjustable BSU in the treatment of SUI by ISD recurrent or non-recurrent.
Comparison of efficacy of extracorporeal magnetic innervation and Kegel exercises for stress urinary incontinence in adult women: study protocol for a randomized controlled trial. [2022]Stress urinary incontinence (SUI) is defined as a complaint of inadvertent loss of urine occurring as a result of an increase in intraabdominal pressure. Strong evidence supports the use of pelvic floor muscle training (PFMT) as the first-line conservative treatment for SUI. Extracorporeal magnetic stimulation (EMS) is a non-invasive, effective, acceptable, and safe therapeutic modality for SUI. Although PFMT and EMS share most of their influences on the pathophysiology of SUI, it is unclear whether one of these routinely used treatment modalities is superior to another in terms of improvement of clinical outcomes or cost-effectiveness. To the best of our knowledge, no randomized controlled trials have so far directly compared PFMT with EMS. Our aim here is to describe a protocol for such a study. This will be a parallel-group, single-blind, randomised controlled trial compliant with the SPIRIT, CONSORT, and TIDieR reporting guidelines. Participants will be women aged 18 to 65 years who have previously given at least one vaginal delivery (at least 12 months before joining the study) who present with symptoms of SUI lasting at least 6 months yet have not previously received treatment for it. In the first study arm, patients will receive an eight-week, high-intensity, home-based Kegel exercises regimen. In the second study arm, the treatment scheme will consist of 2 sessions of EMS per week for a total of eight weeks. The primary outcome will be effectiveness of treatment as measured by the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form overall score, eight weeks, three months, and six months after commencement of treatment.
The Ohmmeter Identifies the Site of Fluid Leakage during Artificial Urinary Sphincter Revision Surgery. [2015]While the AMS 800 artificial urinary sphincter improves continence in up to 90% of patients, revision surgery may be needed in up to 50%. We determined whether an ohmmeter could accurately assess the site of fluid leak from individual components of the artificial urinary sphincter at the time of revision surgery.
Experimental evaluation of an electromechanical artificial urinary sphincter in an animal model. [2019]What's known on the subject? and what does the study add?: The AMS 800 urinary control system is the gold standard for the treatment of urinary incontinence due to sphincter insufficiency. Despite excellent functional outcome and latest technological improvements, the revision rate remains significant. To overcome the shortcomings of the current device, we developed a modern electromechanical artificial urinary sphincter. The results demonstrated that this new sphincter is effective and well tolerated up to 3 months. This preliminary study represents a first step in the clinical application of novel technologies and an alternative compression mechanism to the urethra.
Readjustable midurethral sling (REMEEX system) in obese women. [2020]To evaluate the success rate and patient satisfaction with the readjustable midurethral sling (REMEEX system) for the treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD) or recurrent SUI in obese and non-obese women.
Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency. [2019]We report our experience with the Remeex system™ in women with recurrent stress urinary incontinence (SUI) or intrinsic sphincter deficiency (ISD).
Efficacy and safety of a readjustable midurethral sling (Remeex system) for stress urinary incontinence with female voiding dysfunction. [2019]We investigated the efficacy and safety of a readjustable midurethral sling (Remeex system) for stress urinary incontinence with female voiding dysfunction.
[Clinical research of a butterfly shaped mesh in the treatment of stress urinary incontinence]. [2005]To investigate the effect of a butterfly shaped mesh in treatment of stress urinary incontinence (SUI).
A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies. [2021]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.
Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. [2017]To relate our experience in treating postprostatectomy stress urinary incontinence (SUI) with the male Remeex system (MRS). We also list the elements that comprise this system, the implantation technique and its proper adjustment. Similarly, we attempt to determine whether the latest changes made to this device, which constitute the MRS-II, have resulted in fewer mesh readjustments.