BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCorewell Health East
About this trial
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.
Eligibility criteria
Qualifiers
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.
Females and males, 18 to 80 years of age, inclusive, at screening
Positive Cough or Bladder Stress Test at screening
Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
Disqualifiers
Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
Subject is morbidly obese (defined as body mass index 40 or greater)
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)
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
Trial design
Treatments tested in this trial
- BTL Emsella
- Sham BTL Emsella
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov