Study Comparing the BTL Emsella Chair to Sham Treatment for Stress Urinary Incontinence in Adults Aged 18 to 80

What this Trial Is About

Stress urinary incontinence SUI is a condition causing involuntary urine leakage during activities that increase abdominal pressure, such as coughing or laughing. It affects both men and women and can impact quality of life by limiting daily activities. This trial evaluates the effectiveness of the Emsella chair, which uses electromagnetic technology, compared to a sham treatment to treat SUI. Participants are randomly assigned to either the active treatment group using the Emsella chair or the sham group. The active treatment delivers high-intensity focused electromagnetic stimulation to the pelvic floor muscles, simulating the effect of 11,200 Kegel exercises in 28 minutes. Treatment consists of eight sessions over four weeks, with two sessions per week. The sham group receives a similar procedure with minimal electromagnetic power below therapeutic levels. During the study, participants will undergo assessments of SUI symptoms and quality of life at baseline and after treatment completion. Questionnaires measuring urinary incontinence episodes, symptom severity, urogenital distress, sexual function, and quality of life are collected up to eight weeks after treatment. Safety and tolerability of the device are also monitored. The total study duration includes the 4-week treatment period and follow-up evaluations up to 8 weeks post-treatment.

BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence