An interventional study of Eccentric Training and Concentric Training in Anal Incontinence and Fecal Incontinence, sponsored by San Diego State University. Completed at 1 site in United States. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by San Diego State University · Not applicable, Interventional, and Treatment
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.
Among the 101 studies in Fecal Incontinence with a site in United States, this one is the 34th largest by enrollment of the 79 interventional ones that give a count, is one of 4 that started in 2017, is one of 58 with no phase, and was the 57th registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
Browse Fecal Incontinence studies →14 of the 101 studies in Fecal Incontinence with a site in United States are open now. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Ages 2–30
Cedars-Sinai Medical Center · Sites in United States
Ages 18+
Axonics, Inc. · Sites in United States, United Kingdom
Ages 18+
Axonics, Inc. · Sites in United States, Australia
Ages 18+
David Chu · Sites in United States
Ages 5+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 22 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 5 · Phase 4 5
First in 1998; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 71 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
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.
This tab as a report to print or save as PDF → With an account.
27 of 101 have an industry lead sponsor. The 10 most frequent:
San Diego State University is the lead sponsor of 149 studies on the registry; 43 are open to participants now.
San Diego State University has 1 study filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
11 of the studies in Fecal Incontinence with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05776277Phase 3Cook MyoSiteIltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury | 2026-12 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Add all 11 to your calendar (.ics) → With an account.
Among the 101 studies in Fecal Incontinence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known to cause muscle strengthening and hypertrophy in other muscles in the body. This study aims to investigate whether a novel pelvic floor resistance exercise program will increase pelvic floor muscle strength and improve anal incontinence and has the potential to impact rehabilitation strategies for the millions of women affected anal incontinence.
The current proposal is focused on examining whether a novel resistance exercise program for the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal incontinence. Anal incontinence is a significant public health issue that is estimated to impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles, however, these exercises are performed with no resistance. There is a large body of evidence indicating that for muscle strengthening and hypertrophy to occur, exercises must be performed against resistance. Therefore, we have designed a novel exercise program for the pelvic floor that incorporates principals of resistance training known to be effective in other muscles in the body. The long-term goal of this research is to determine the most appropriate noninvasive strategies and interventions to improve pelvic floor function and symptoms of anal incontinence. This project is the first step in achieving this goal. The overall purpose of the current proposal is to determine whether novel physical therapy interventions are more effective than traditional biofeedback strategies in the treatment of anal incontinence. The specific aims of the proposal are: (1) To describe the use of the Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether eccentric, concentric, or isometric exercise training of the pelvic floor has a positive impact on the pelvic floor muscles and on symptoms of anal incontinence compared to traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as effective as its use in the anal canal for treatment of anal incontinence. To test these aims, the approach includes a randomized controlled exercise trial with use of validated measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal describes an innovative approach to rehabilitation of the pelvic floor muscles that will provide information about pelvic floor function and that has the potential to shift the treatment paradigm for women with pelvic floor disorders.
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.
Exclusion Criteria:
Behavioral: Eccentric Training
Behavioral: Concentric Training
Behavioral: Isometric Training
Behavioral: Biofeedback
Different Anal Sphincter Exercise Types for muscle hypertrophy
Different Anal Sphincter Exercise Types for muscle hypertrophy
Different Anal Sphincter Exercise Types for muscle hypertrophy
Standard of Care Biofeedback Training
Change in Length Tension Manometry after 12 weeks
change from baseline to 12 weeks
Time frame: 12 weeks
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
change from baseline to 12 weeks
Time frame: 12 weeks
Change in FISI score after 12 weeks
change from baseline to 12 weeks
Time frame: 12 weeks
Change in Length Tension Manometry after 1 year
change from baseline to 12 months
Time frame: 12 months
Change in Length Tension Manometry after 2 years
change from baseline to 24 months
Time frame: 24 months
Change in Muscle Hypertrophy (ultrasound) after 1 year
change from baseline to 12 months
Time frame: 12 months
Change in Muscle Hypertrophy (ultrasound) after 2 years
change from baseline to 24 months
Time frame: 24 months
Change in FISI score after 1 year
change from baseline to 12 months
Time frame: 12 months
Change in FISI score after 2 years
change from baseline to 24 months
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Jun 2022, 57 months.
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 57 months is above 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.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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