Actively Recruiting
BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Led by Corewell Health East · Updated on 2025-12-11
110
Participants Needed
1
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and provide written informed consent and comply with study procedures
- Male or female aged 18 to 80 years at screening
- Positive cough or bladder stress test at screening
- Agree not to start new treatments during the treatment and follow-up periods
- Agree to maintain stable doses of medications affecting urinary tract function during the study
- Females must discontinue bladder support devices and use approved birth control if of child-bearing age
- Males must be at least 4 months post radical prostatectomy
You will not qualify if you...
- Pelvic floor physical therapy or electrostimulation within 30 days prior to screening
- Morbid obesity (BMI 40 or greater)
- Pulmonary insufficiency or related symptoms
- Conditions causing lack of normal skin sensation in pelvis, buttocks, or lower extremities
- Implanted cardiac pacemaker or metal in the body
- Piercing between waist and knees unwilling to be removed before treatment
- Active urethral diverticula
- Known vesicoureteral reflux
- Healing from surgery where muscle contraction may disrupt healing
- Urethral bulking agents treatment within 6 months prior to screening
- Current treatment for malignant tumors interfering with participation
- Prior use of the BTL Emsella device
- Urinary incontinence of neurogenic origin
- Active urinary tract infection at screening
- Participation in another investigational study within 30 days
- Any physical condition posing risk or interfering with study
- Females who are pregnant, planning pregnancy, or with vaginal mesh surgery for SUI
- Vaginal prolapse beyond the introitus
- Vaginal rejuvenation treatment within 6 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
Research Team
J
Julie Swanson, RN
CONTACT
J
Jennifer Giordano, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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