Fecal IncontinenceNCT07034443
Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
A study testing High Intensity Focused Electromagnetic Stimulation in people with Fecal Incontinence, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- High Intensity Focused Electromagnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 18 years old or older are included.
- Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU
- Must be at least 1 year out from J pouch surgery
- Have fecal incontinence
Who cannot join
- Any records flagged "break the glass" or "research opt out."
- Pediatric Patients <18 years of age
- Did not receive a J pouch
- Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis
- Have active pouchitis
- Have an active fistula
Show all 9Show fewer
- If reclassified to de novo Crohn's after surgery
- Have implanted metal devices or medical devices
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Karen Zaghiyan, MD, 3102899224, karen.zaghiyan@cshs.org
Gayane Ovsepyan, MPH, 3102899224, gayane.ovsepyan@cshs.org
About this study
Official title: Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot 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.
- Conditions
- Fecal Incontinence
- Being tested
- High Intensity Focused Electromagnetic Stimulation
- Keywords
- Ulcerative colitis, Fecal Incontinence, Functional Outcomes, High Intensity Focused Electromagnetic Stimulation, J pouch
- Medical subject headings
- Fecal Incontinence, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused Electromagnetic StimulationDevice
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Focused Electromagnetic Stimulation | Experimental | This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation Receives: Device: High Intensity Focused Electromagnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Patient Reported Outcomes Measurement Information System Score (PROMIS 10), scaled from 0-20 evaluate patient overall quality of life. Higher score indicates better health
Measured: baseline, 1 month and 3 months
Secondary outcomes (6)
Determine change in sexual function and satisfaction in patients at treatment determined by Patient Reported Outcomes Measurement Information System Score sexual function scale
Patient Reported Outcomes Measurement Information System Score (PROMIS) sexual function, scored 0-20 to evaluate patient sexual health. Higher score indicates better sexual function
Measured: baseline, 1 month, 3 months
Determine change in fecal incontinence, as determined by change in Wexner scale from baseline
The Wexner Scale ranges from 0-20, with 0 being perfect continence and 20 being complete incontinence
Measured: baseline, 1 and 3 months
Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI
POPDI6 (Pelvic Organ Prolapse Distress Inventory). Score 0-20 with higher score reflecting more severe symptoms of pelvic organ dysfunction.
Measured: baseline, 1 and 3 months
Determine if change in pelvic organ dysfunction as determined by IPSS
IPSS (International Prostate Symptom Score). Scored 0-20. Higher score indicates more severe symptoms of prostate dysfunction
Measured: baseline, 1 month and 3 months
Determine if change in pelvic organ dysfunction as determined by CRAD- 9
CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction.
Measured: baseline, 1 month and 3 months
Determine if change in pelvic organ dysfunction as determined by UD16
UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Zaghiyan, Cedars-Sinai Medical Center
- Investigators
- Karen Zaghiyan, MD, Principal investigator, Cedar Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034443
- Sponsor's protocol ID
- STUDY00003888
- Status last verified
- Aug 2026
- First submitted
- 16 May 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: PI preference
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07034443
- Acronym / sponsor ID
- STUDY00003888
- Conditions
- Fecal Incontinence
- Keywords
- Ulcerative colitis, Fecal Incontinence, Functional Outcomes, High Intensity Focused Electromagnetic Stimulation, J pouch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Electromagnetic Stimulation | Experimental | Device: High Intensity Focused Electromagnetic StimulationThis will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals 18 years old or older are included.
- Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU
- Must be at least 1 year out from J pouch surgery
- Have fecal incontinence
Key exclusion criteria (9 listed)
- Any records flagged "break the glass" or "research opt out."
- Pediatric Patients <18 years of age
- Did not receive a J pouch
- Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis
- Have active pouchitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused Electromagnetic StimulationPatients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks | Device | High Intensity Focused Electromagnetic Stimulation |
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
6 secondary outcomes
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
Determine change in fecal incontinence, as determined by change in Wexner scale from baseline
Time frame: baseline, 1 and 3 months
Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI
Time frame: baseline, 1 and 3 months
Determine if change in pelvic organ dysfunction as determined by IPSS
Time frame: baseline, 1 month and 3 months
Determine if change in pelvic organ dysfunction as determined by CRAD- 9
Time frame: baseline, 1 month and 3 months
Determine if change in pelvic organ dysfunction as determined by UD16
Time frame: Baseline, 1 month and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. PI preference
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Zaghiyan, MD principal investigator
Cedar Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Electromagnetic Stimulation in people with Fecal Incontinence, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samara Spence, MD (6037323655, samara.spence@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.