Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04873037

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Led by Corewell Health East · Updated on 2025-12-11

166

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

CONDITIONS

Official Title

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to read, understand, and provide written informed consent and likely to comply with study procedures
  • Men and women aged 18 years or older
  • Self-reported bladder symptoms present for 3 months or more
  • Self-reported failure of conservative care including behavioral changes or oral medications
  • On a stable dose of antimuscarinics or beta-3 agonists for at least 4 weeks and willing to continue, or discontinued these medications for at least 2 weeks
  • Able to walk and use a toilet independently without difficulty
  • Agree not to start any new treatment for overactive bladder during the study treatment and follow-up
  • For females of child-bearing age, agree to use approved birth control methods
Not Eligible

You will not qualify if you...

  • Botox use in bladder or pelvic floor muscles within the past year
  • Weighing more than 330 pounds
  • Pulmonary insufficiency causing breathing difficulty or fatigue
  • Conditions causing loss of normal skin sensation in pelvis, buttocks, or thighs
  • Major metal implants such as plates, screws, joint replacements, pacemakers, drug pumps, neurostimulators, electronic implants, copper IUDs, defibrillators, or pelvic metal implants
  • Having a piercing between waist and knees that cannot be removed before treatment
  • Active urethral diverticula
  • Known vesicoureteral reflux
  • Healing from surgery that would be disrupted by muscle contractions
  • Current treatment for malignant tumors interfering with participation (skin cancers allowed)
  • Previous use of BTL EMSELLA device
  • Urinary incontinence caused by neurological diseases like multiple sclerosis or spinal cord injury
  • Current urinary tract infection
  • Use of neuromodulation therapy for bladder symptoms within 3 months
  • Participation in another investigational study or use of investigational drugs within 30 days
  • Any physical condition that may increase risk or affect study results
  • For females, pregnancy or planning pregnancy during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

D

Danielle Tenney

CONTACT

J

Jennifer Giordano, BSN

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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