BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence (NCT04138602) | Clinical Trial Compass
WithdrawnNot Applicable
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
Stopped: Lack of enrollment
United States0Started 2020-09-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
compare the efficacy of Emsella Chair to sham by evaluating the responder rate, where a subject is called a responder if there is ≥ 50% reduction from baseline in the number fecal incontinence episodes reported over 7 days on the bowel diary.
Timeframe: 4 weeks after completing all treatments
✕. 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