Study Comparing Emsella Chair to Sham Treatment for Overactive Bladder in Adults

What this Trial Is About

Overactive bladder OAB is a common condition affecting both men and women, characterized by symptoms like urinary frequency, urgency, and incontinence. This trial evaluates the BTL Emsella Chair, a device using high-intensity focused electromagnetic HIFEM technology, compared to a sham treatment, to see if it effectively treats OAB. The study is a randomized, double-blind trial aiming to provide a noninvasive alternative due to the challenges and side effects of current pharmacologic treatments. Participants will receive either the active Emsella Chair treatment or a sham treatment twice a week for four weeks. The active treatment involves sitting on the chair while electromagnetic stimulation induces deep pelvic floor muscle contractions, aiming to simulate thousands of Kegel exercises. The sham group will experience similar positioning but with limited stimulation below therapeutic levels. Treatment intensity is adjusted based on individual tolerance and increased over time. Throughout the study, participants will be assessed for improvement in bladder symptoms using questionnaires such as the Global Response Assessment and the Overactive Bladder Questionnaire. They will keep a voiding diary to record urinary urgency, frequency, and leakage episodes. Safety and tolerability will also be monitored. The main outcomes are measured four weeks after treatment completion, with follow-up extending to 12 weeks to assess durability of response. Total participation lasts about eight to twelve weeks.

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder