Extracorporeal magnetic innervation therapy for stress urinary incontinence.
N T Galloway, R E El-Galley, P K Sand...
https://pubmed.ncbi.nlm.nih.gov/10367836Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04133675
A Single-Blind, Randomized Study of the 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
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stress urinary incontinence (SUI) affects both men and women and involves involuntary urine leakage caused by activities that increase pressure in the abdomen, such as exercise, coughing, laughing, or sneezing. This trial evaluates whether the Emsella chair, which uses electromagnetic technology, is effective in treating SUI by comparing it to a sham treatment. The study is a prospective, randomized, double-blind trial designed to gather data on this novel therapy. Participants will be randomly assigned to receive either active treatment with the Emsella chair or a sham treatment in equal numbers. The active treatment involves sitting on the chair for 28 minutes per session, during which high-intensity focused electromagnetic (HIFEM) technology stimulates deep pelvic floor muscle contractions equivalent to performing 11,200 Kegel exercises. Eight treatments will be given over four weeks, twice weekly. The sham group will receive a non-therapeutic setting that provides some sensation without active stimulation. Throughout the study, participants will undergo assessments to measure the effect of treatment on stress urinary incontinence, including the number of leakage episodes, severity, quality of life, and sexual function. These evaluations take place up to eight weeks after completing all treatments. Safety and tolerability of the Emsella chair will also be monitored. Participants will complete questionnaires and physical tests during and after the treatment period, with final follow-up lasting up to eight weeks after the last session.
CONDITIONS
Brief Title
BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and provide written, dated informed consent before screening
- Male or female aged 18 to 80 years inclusive at screening
- Positive cough or bladder stress test at screening
- Agree not to start any new treatments during treatment and follow-up periods
- Maintain stable doses of medications affecting lower urinary tract function during treatment and follow-up
- For females: agree to stop using bladder support devices during study periods
- For females of child-bearing age: agree to use approved birth-control methods
- For males: at least 4 months post radical prostatectomy
You will not qualify if you...
- Pelvic floor physical therapy or electrostimulation within 30 days before 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 devices including IUDs and defibrillators
- Piercing between waist and knees not removable before treatment
- Active urethral diverticula
- Known vesicoureteral reflux
- Healing surgical procedures where muscle contraction might disrupt healing
- Urethral bulking agents treatment within 6 months prior to screening
- Current treatment for malignant tumor interfering with participation
- Previous use of BTL EMSELLA device
- Urinary incontinence from neurogenic causes
- Clinically confirmed urinary tract infection at screening
- Participation in other investigational studies within 30 days prior to screening
- Any physical condition posing risk or interfering with study interpretation
- For females: pregnant or planning pregnancy during study
- History of vaginal mesh surgery for SUI
- Vaginal prolapse beyond introitus
- Vaginal rejuvenation treatments within 6 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 4 weeks
Participants receive either active treatment or sham treatment using the BTL Emsella Chair. Treatment involves electromagnetic stimulation of pelvic floor muscles to improve stress urinary incontinence.
8 treatments, 2 treatments each week
Follow-up
Duration - 8 weeks after completing all treatments
Participants are monitored to assess the efficacy and safety of the treatment over time.
Visits for assessment occurring up to 8 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
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Research Team
J
Julie Swanson, RN
J
Jennifer Giordano, RN
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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