Electromagnetic Stimulation for Fecal Incontinence

Overseen By Gayane Ovespyan, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Pediatric, Crohn's, Pouchitis, Fistula, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the Emsella chair, which uses electromagnetic stimulation, in helping individuals with fecal incontinence (difficulty controlling bowel movements) after J pouch surgery. The focus is on those who underwent this surgery due to Ulcerative Colitis or IBDU, aiming to determine if the treatment improves their quality of life. Individuals who had J pouch surgery at least a year ago and continue to experience fecal incontinence may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electromagnetic stimulation is safe for patients with fecal incontinence?

Research has shown that the Emsella chair, which uses focused electromagnetic waves, is generally well-tolerated. Some studies mention common side effects like mild discomfort, such as pain in the legs or stomach. These effects are usually temporary and not serious. In another study, some participants felt tingling or found the chair's power somewhat strong. However, these effects are manageable, and most do not find them too bothersome. Overall, current research indicates that the treatment appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emsella chair for treating fecal incontinence because it uses High Intensity Focused Electromagnetic (HIFEM) stimulation, offering a non-invasive alternative to traditional methods like medications, dietary changes, or surgery. This technology works by strengthening pelvic floor muscles through electromagnetic pulses, potentially improving muscle control and reducing incontinence episodes. Unlike other treatments that can be invasive or require lifestyle changes, the Emsella chair allows patients to sit comfortably while receiving therapy, making it a convenient and painless option.

What evidence suggests that the Emsella chair is effective for fecal incontinence?

Research has shown that the Emsella chair, which uses focused electromagnetic technology, may help treat fecal incontinence. In this trial, participants will receive High Intensity Focused Electromagnetic Stimulation using the Emsella chair. One study found that patients experienced noticeable improvements in their symptoms after using this technology. The high-intensity electromagnetic stimulation strengthens the pelvic floor muscles, which are crucial for controlling bowel movements. Another study found that the Emsella chair effectively reduced the severity of fecal incontinence. These findings suggest that the Emsella chair could be a helpful treatment for those dealing with fecal incontinence. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen Zaghiyan, MD

Principal Investigator

Cedar Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Ulcerative Colitis or Inflammatory Bowel Disease who have undergone surgery to create a J pouch (IPAA) and are experiencing fecal incontinence. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 18 years old or older.

Have fecal incontinence

I have a J pouch due to Ulcerative Colitis or IBDU.

Exclusion Criteria

Have an active fistula

Any records flagged 'break the glass' or 'research opt out'

I currently have active pouchitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive High Intensity Focused Electromagnetic Stimulation using the Emsella chair

3 months

Regular visits at baseline, 1 month, and 3 months

Follow-up

Participants are monitored for changes in pelvic organ dysfunction, quality of life, and fecal incontinence

3 months

Follow-up assessments at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Emsella chair

Trial Overview

The study is testing the effectiveness of High Intensity Focused Electromagnetic Stimulation, using an Emsella chair, on improving control over bowel movements and overall quality of life in patients with a J pouch.

How Is the Trial Designed?

Group I: High Intensity Focused Electromagnetic Stimulation Experimental Treatment 1 Intervention

This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8016513/

A Comparative Study on the Effects of High-Intensity ...

BioBravo portable low-frequency stimulator is used for self-administered PFMs stimulation to treat urinary/fecal incontinence symptoms (approved by European ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7005914/

Effects of Extracorporeal Magnetic Stimulation in Fecal ...

Fecal incontinence (FI) is defined as the involuntary loss of solid or liquid feces. It is a prevalent condition with unpleasant consequences ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04873037

BTL Emsella Chair Versus Sham for the Treatment ...

A higher score indicates a greater severity of fecal incontinence. 4 weeks after completing all treatments; week 8 of the study. The secondary durability ...

4.

springwellclinic.co.uk

springwellclinic.co.uk/news/a-comparison-study-of-hifem-technology-used-in-emsella-treatments/

A study of HIFEM technology used in Emsella Treatments

... Emsella chair treatment for incontinence. Group II – BioBravo is a portable, low-frequency stimulator used at home to treat urinary or fecal ...

5.

cms.gov

cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=61

Pelvic Floor Electrical Stimulation for Urinary Incontinence

The percentage of patients with diagnosis of urge incontinence decreased from 54% to 27% after treatment, whereas the change in pre/post treatment diagnosis was ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04031014?cond=Electromagnetic%20field&aggFilters=status:not%20rec%20ava&rank=7

High Intensity Focused Electromagnetic Field Device for ...

Also called a data safety and monitoring board, or DSMB. ... Pelvic floor dysfunction is common and can include symptoms of urinary incontinence, fecal ...

7.

mcgs.bcbsfl.com

mcgs.bcbsfl.com/MCG?mcgId=01-97000-06&pv=false

Subject: Pelvic Floor Stimulation as a Treatment of Incontinence

Electrical stimulation of the pelvic floor is also proposed as a treatment of fecal incontinence. Pelvic floor stimulation (PFS) involves ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10383588/

Evaluation of Possible Side Effects in the Treatment of Urinary ...

Lower limb pain (9), abdominal pain (7), cystitis (6), bowel symptoms (6), backache (5), chair powerful (3), difficult positioning (2), tingling ...

9.

medcraveonline.com

medcraveonline.com/IPMRJ/safety-and-efficacy-of-non-invasive-high-intensity-focused-electromagnetic-stimulation-to-improve-quality-of-life-and-pelvic-floor-muscle-function-in-women-with-pelvic-organ-prolapse-a-pilot-study.html

Safety and efficacy of non-invasive, high-intensity, focused ...

Common defecatory symptoms include constipation and a sensation of incomplete bowel emptying.11 Furthermore, women with POP may avoid sexual ...