Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-31 @ 5:08 PM
Study NCT ID:
NCT04138602
Status:
WITHDRAWN
Last Update Posted:
2020-09-03
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
A Single-Blind, Randomized, Pilot Study of the BTL Emsella Chair With Dietary Counseling Versus Sham Chair With Dietary Counseling for the Treatment of Fecal Incontinence
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Fecal incontinence, no matter how frequent, may significantly affect a patient's quality of life. Current available treatment options include; establishing a bowel regimen that consists of supplements, over the counter medications (stool softeners, laxatives, anti-diarrheal, enemas), or utilizing other prescription drugs (Linzees, Lomotil). Other conservative treatments include biofeedback therapy with a physical therapist. More invasive procedures include the injection of bulking agents or sacral nerve stimulation implantation.
The Emsella chair is currently approved as a treatment for stress urinary incontinence. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
Subjects meeting eligibility will be randomized (1:1) to receive treatment with the Emsella chair and dietary counseling or sham Emsella chair with dietary counseling. A total of 8 treatments (2 treatments per week for 4 weeks) will be completed. For treatment delivery, participants will sit on the device and the chair height will be adjusted to ensure the subject's feet are on the floor. The sham Emsella treatment will provide some sensation without active HIFEM technology.
The Emsella chair is currently approved as a treatment for stress urinary incontinence. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
Subjects meeting eligibility will be randomized (1:1) to receive treatment with the Emsella chair and dietary counseling or sham Emsella chair with dietary counseling. A total of 8 treatments (2 treatments per week for 4 weeks) will be completed. For treatment delivery, participants will sit on the device and the chair height will be adjusted to ensure the subject's feet are on the floor. The sham Emsella treatment will provide some sensation without active HIFEM technology.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: