BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Fecal Incontinence

In brief

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

Key facts

Study ID

NCT04138602

Run by

Corewell Health East

People needed

0

Starts

2020-09-01

Expected to finish

2020-09-01

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
• Women and men, 18 years of age or older
• Subject reported fecal incontinence
• Up to date on screening colonoscopy per guidelines (USPSTF)
• Willingness to comply with conservative dietary management
• Subject agrees to maintain a stable dose of any medication, prescribed or over the counter, known to affect bowel functioning.
• Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
• If of child-bearing age, agree to practice approved birth-control methods listed in appendix C

You may not qualify if…

• Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
• Subject weighs more than 330 pounds
• Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
• Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
• Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
• Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study
• Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
• Currently healing from surgical procedures where muscle contraction may disrupt the healing process
• Subject has a malignant tumor, in any location of the body
• Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit
• Subject has used the BTL EMSELLA device previously
• Neurologic conditions deemed exclusionary by an investigator, including multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
• Chronic pelvic pain > 4/10 VAS
• Undiagnosed/unmanaged disorders of motility, including Irritable Bowel Syndrome (IBS)
• Undiagnosed colorectal conditions
• Bowel surgery in the past 12 months
• Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
• Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
• To preserve the integrity of the study, some criteria have been omitted. All criteria will be available to the public at the close of the study.

Where it is running

• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.