Fecal Incontinence
Electromagnetic Stimulation for Fecal Incontinence After J-Pouch Surgery
This single-group pilot study evaluates fecal incontinence, quality of life, sexual function, and pelvic-organ symptoms after high-intensity focused electromagnetic stimulation in adults who received a J-pouch for ulcerative colitis or inflammatory bowel disease-unclassified.
Registry title: Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- High Intensity Focused Electromagnetic Stimulation
- Design
- Not provided
- Central study contact
- Samara Spence, MD6037323655samara.spence@cshs.org
- Sponsor
- Cedars-Sinai Medical Center
Research question
How do fecal incontinence, health-related quality of life, sexual function, and pelvic-organ symptoms change during and after a course of high-intensity focused electromagnetic stimulation in this J-pouch population?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- Participants must have received J-pouch reconstruction because of ulcerative colitis or inflammatory bowel disease-unclassified.
- Participants must be at least one year past their J-pouch surgery and have fecal incontinence.
- The registry lists one recruiting study location at Cedars-Sinai Medical Center in Los Angeles, California.
Participation overview
What participation may involve
Participants receive seated electromagnetic stimulation twice weekly for three weeks and complete patient-reported assessments at baseline, one month, and three months. What participation may involve: - Sit on the electromagnetic stimulation device for 28 minutes, twice a week for three weeks. - Complete the Patient-Reported Outcomes Measurement Information System 10 assessment of overall quality of life at baseline, one month, and three months. - Complete questionnaires about sexual function, fecal incontinence, and pelvic-organ symptoms at baseline, one month, and three months. The treatment course lasts three weeks, and reported outcome assessments extend through three months; the registry does not state the full participation period.
Study interventions
What participants may receive or do
- High Intensity Focused Electromagnetic Stimulation: Participants sit on the device for 28-minute high-intensity electromagnetic stimulation sessions twice weekly for three weeks.
Study design
How the comparison works
This is an interventional, single-group pilot study with an estimated enrollment of 20 participants; everyone is assigned to the electromagnetic stimulation group. The registry lists allocation as not applicable because the study has only one intervention group. The study has no masking, so participants and researchers are not described as blinded to the intervention. No separate control or comparison group is described. No placebo or sham intervention is described; the single listed group receives electromagnetic stimulation.
Reported activities
Procedures and tests
- High-intensity focused electromagnetic stimulation while seated on the study device for 28 minutes.
- Patient-Reported Outcomes Measurement Information System 10 questionnaire for overall quality of life.
- Patient-Reported Outcomes Measurement Information System sexual-function questionnaire.
- Wexner Scale assessment of fecal incontinence.
- Pelvic Organ Prolapse Distress Inventory assessment of pelvic-organ symptoms.
- International Prostate Symptom Score assessment.
- Colorectal Anal Distress Inventory assessment.
- Urinary Distress Inventory assessment.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be age 18 or older.
- Participants must have a J-pouch reconstruction performed because of ulcerative colitis or inflammatory bowel disease-unclassified.
- At least one year must have passed since J-pouch surgery.
- Participants must have fecal incontinence.
Possible reasons someone may not be able to join
- People whose records are flagged "break the glass" or "research opt out" are excluded.
- People younger than 18 are excluded.
- People who did not receive a J-pouch are excluded.
- People whose J-pouch was created for a reason other than ulcerative colitis or inflammatory bowel disease-unclassified are excluded; the registry specifically names Crohn's disease and familial adenomatous polyposis as examples.
- People with active pouchitis are excluded.
- People with an active fistula are excluded.
- People reclassified as having de novo Crohn's disease after surgery are excluded.
- People with implanted metal devices or implanted medical devices are excluded.
- Pregnant people are excluded.
Important unknowns
What the record does not make clear
- The registry reports treatment twice weekly for three weeks and assessments at baseline, one month, and three months, but it does not provide a complete visit schedule or say whether assessment and treatment appointments are combined.
- Treatment lasts three weeks and outcome assessments extend through three months, but the complete participation period is not explicitly stated.
- The registry does not say whether participants continue their usual medications, pelvic-floor care, or other treatments during the study.
- The registry does not report whether any medications must be stopped or changed before treatment.
- The registry does not describe what treatment is available if fecal incontinence, pouchitis, or other symptoms worsen.
- The registry does not state whether pouchoscopy, endoscopy, imaging, or other procedures are required to confirm the absence of active pouchitis or fistula.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants are compensated.
- The registry does not report reimbursement or support for travel, parking, lodging, or related expenses.
- The registry does not state whether any screening or follow-up assessments may be completed remotely.
- The registry does not describe access to the device treatment after study participation ends.
Before contacting the site
Questions for the study team
- What is the complete appointment schedule, including screening, treatment sessions, and follow-up assessments?
- How will the study team determine whether pouchitis or a fistula is active, and are pouchoscopy, imaging, or other tests required?
- Which medications, pelvic-floor treatments, or other therapies may continue during the study, and must anything be stopped?
- What discomforts, risks, or reasons for stopping treatment are associated with the electromagnetic stimulation device?
- Which costs are covered, and are compensation, parking reimbursement, or other travel support available?
- Can any screening or follow-up questionnaires be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable are my pouch symptoms, and is there any concern for active pouchitis, an active fistula, or Crohn's disease after surgery?
- Could study participation require changes to my current inflammatory bowel disease, continence, or pelvic-floor treatment?
- What approved or standard-care alternatives could address my fecal incontinence, and how do their known risks and goals compare with this research study?
- If I contact the study, how should my gastroenterology team and the research team coordinate monitoring and care if my pouch symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.
Study design and administration
- Organization
- Cedars-Sinai Medical Center
- Organization class
- Other
- Organization study ID
- STUDY00003888
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
High Intensity Focused Electromagnetic Stimulation
This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation
Interventions: Device: High Intensity Focused Electromagnetic Stimulation
Interventions
Device
High Intensity Focused Electromagnetic Stimulation
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (4)
- Individuals 18 years old or older are included.Registry-derived · unreviewed
- Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDURegistry-derived · unreviewed
- Must be at least 1 year out from J pouch surgeryRegistry-derived · unreviewed
- Have fecal incontinenceRegistry-derived · unreviewed
Exclusion criteria (9)
- Any records flagged "break the glass" or "research opt out."Registry-derived · unreviewed
- Pediatric Patients \<18 years of ageRegistry-derived · unreviewed
- Did not receive a J pouchRegistry-derived · unreviewed
- Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposisRegistry-derived · unreviewed
- Have active pouchitisRegistry-derived · unreviewed
- Have an active fistulaRegistry-derived · unreviewed
- If reclassified to de novo Crohn's after surgeryRegistry-derived · unreviewed
- Have implanted metal devices or medical devicesRegistry-derived · unreviewed
- Pregnant patientsRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Determine if patients have change in overall quality of live, as determined by statistically significant change in Patient Reported Outcomes Measurement Information System 10 Score from baseline
Time frame: baseline, 1 month and 3 months
Patient Reported Outcomes Measurement Information System Score (PROMIS 10), scaled from 0-20 evaluate patient overall quality of life. Higher score indicates better health
Secondary outcome
Determine change in sexual function and satisfaction in patients at treatment determined by Patient Reported Outcomes Measurement Information System Score sexual function scale
Time frame: baseline, 1 month, 3 months
Patient Reported Outcomes Measurement Information System Score (PROMIS) sexual function, scored 0-20 to evaluate patient sexual health. Higher score indicates better sexual function
Secondary outcome
Determine change in fecal incontinence, as determined by change in Wexner scale from baseline
Time frame: baseline, 1 and 3 months
The Wexner Scale ranges from 0-20, with 0 being perfect continence and 20 being complete incontinence
Secondary outcome
Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI
Time frame: baseline, 1 and 3 months
POPDI6 (Pelvic Organ Prolapse Distress Inventory). Score 0-20 with higher score reflecting more severe symptoms of pelvic organ dysfunction.
Secondary outcome
Determine if change in pelvic organ dysfunction as determined by IPSS
Time frame: baseline, 1 month and 3 months
IPSS (International Prostate Symptom Score). Scored 0-20. Higher score indicates more severe symptoms of prostate dysfunction
Secondary outcome
Determine if change in pelvic organ dysfunction as determined by CRAD- 9
Time frame: baseline, 1 month and 3 months
CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction.
Secondary outcome
Determine if change in pelvic organ dysfunction as determined by UD16
Time frame: Baseline, 1 month and 3 months
UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction
Recruiting locations in the United States
Cedars Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
Karen Zaghiyan, MD3102899224karen.zaghiyan@cshs.org
Gayane Ovsepyan, MPH3102899224gayane.ovsepyan@cshs.org
Samara S Spence, MD
Central study contacts
Registry dates
- First posted
- Jun 24, 2025
- Primary completion
- Jul 1, 2027
- Overall completion
- Jul 1, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.