ClinicalTrials.gg
RecruitingNCT07034443Updated Aug 12, 2026

Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation

An interventional study of High Intensity Focused Electromagnetic Stimulation in Fecal Incontinence, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 101 studies in Fecal Incontinence with a site in United States — 14 open to participants now, 19 under way, 2 of them phase 3. Fecal Incontinence · United States.

Planned enrollment
57th of 79
20 · median 44
Started
2026
with 4 others
No phase
58 of 101
10 open now
Primary completion
2027-07
later than 11 of 18 live
Registered
97th of 101
by date
Lead sponsor
3 of 101
Cedars-Sinai Medical Center

Among the 101 studies in Fecal Incontinence with a site in United States, this one is the 57th largest by planned enrollment of the 79 interventional ones, is one of 5 that started in 2026, is one of 58 with no phase, reaches primary completion later than 11 of the 18 other live ones, and was the 97th registered.

By phase

101 studies; the count open now beside each. This study's row is marked.

No phasethis study58 · 10 open
Observational21 · 4 open
Phase 15 · 0 open
Phase 45 · 0 open
Phase 24 · 0 open
Phase 34 · 0 open
Phase 1/22 · 0 open
Other kind1 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1998; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 44 across the 79 interventional studies, 80 across the 21 observational. Of the 70 that completed or were terminated, 35 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 101 studies in Fecal Incontinence with a site in United States, or all of them as a file.
02

Study 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. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.

03

Conditions studied

  • Fecal Incontinence

Keywords

  • Ulcerative colitis
  • Fecal Incontinence
  • Functional Outcomes
  • High Intensity Focused Electromagnetic Stimulation
  • J pouch
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • If reclassified to de novo Crohn's after surgery
  • Have implanted metal devices or medical devices
  • Pregnant patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

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

    Device: High Intensity Focused Electromagnetic Stimulation

Interventions

  • DeviceHigh Intensity Focused Electromagnetic Stimulation

    Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline, 1 month and 3 months

Secondary outcomes

  1. 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

    Time frame: baseline, 1 month, 3 months

  2. 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

    Time frame: baseline, 1 and 3 months

  3. 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.

    Time frame: baseline, 1 and 3 months

  4. 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

    Time frame: baseline, 1 month and 3 months

  5. 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.

    Time frame: baseline, 1 month and 3 months

  6. 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

    Time frame: Baseline, 1 month and 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — PI preference

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.

Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 11 months is below that.

Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2025
First posted
Jun 24, 2025
StartEst.
Aug 1, 2026
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07034443
Responsible party
Karen Zaghiyan (Colon and Rectal Surgeon, Cedars-Sinai Medical Center) — Principal investigator
First posted
Jun 24, 2025
Start date
Aug 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Samara Spence, MD
Contact
samara.spence@cshs.org
6037323655
Gayane Ovespyan, MPH
Contact
gayane.ovespyan@cshs.org
3102899224
Karen Zaghiyan, MD
principal investigator · Cedar Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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