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โ† Trials
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BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

RecruitingNAAges 18 Years - 80 YearsAllCorewell Health East
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In plain words

What the trial is, and whether it could suit you

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information. 2. Females and males, 18 to 80 years of age, inclusive, at screening 3. Positive Cough or Bladder Stress Test at screening 4. Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods. 6\. Subject agrees to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonist, or ฮฑ-adrenergic blockers, throughout the treatment and follow-up periods. For Females Only: * Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods. * If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s)) For Males Only: \- Subject must be โ‰ฅ 4 months post radical prostatectomy Exclusion Criteria: 1. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening 2. Subject is morbidly obese (defined as body mass index 40 or greater) 3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure or tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis) 4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities 5. Implanted cardiac pacemaker or metal in the body, including, but not limited to drug pumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs), and/or defibrillators 6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment 7. Active urethral diverticula 8. Known vesicoureteral reflux 9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process 10. Treatment with urethral bulking agents within the 6 months prior to the Screening Visit 11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. 12. Subject has used the BTL EMSELLA device previously 13. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc. 14. Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit 15. Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit 16. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation For Females Only: 17. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period 18. History of surgery with insertion of vaginal mesh for SUI 19. Vaginal prolapse beyond the introitus 20. Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit * Note for the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
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What it tests

  • BTL Emsella
  • Sham BTL Emsella
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Where

1 site
Corewell Health William Beaumont University Hospital
Royal Oak, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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