Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT06532123

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

continence muscles resistance device

Study Details

Brief summary:

The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.

Conditions

Fecal Incontinence

Study ID

NCT06532123

Start date

Jul 15, 2025

Status verified date

Oct, 2025

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy volunteers without past or present history of fecal incontinence
  • Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study

Exclusion Criteria:

  • Any one less than 18 years old
  • Neurological disorders like dementia, cerebrovascular diseases
  • Muscle diseases like muscular dystrophy, myopathies
  • Inflammatory bowel disease or celiac disease
  • Neuro-muscular junction disorders/myasthenia gravis, Eaton-Lambert syndrome
  • Organ prolapse, large rectocele(>2cm), rectal intussusception
  • Hip dysplasia or recent hip surgery and immobile patients.
  • Patients with complete normal anal resting and squeeze pressure
  • Impaired rectal evacuation (dyssynergy defecation)
  • Fecal incontinence completely due to loss of rectal sensation
  • Subjects unable to contract their external anal sphincter at all

Study Design

Enrollment

340 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: fatigability of various striated continence muscles healthy adults

Device: anorectal manometry/vaginal manometry (female) with and without applying c-RED Participants will do repetitive anal contraction and sustained contraction without device and with device in a random order. For contraction with the device, three different resistance level will be applied as described previously.

For isometric contraction, the annal balloon of the device will be inflated to internal pressure of 500mmHg, which is noncompressible. Participants will repeat the repetitive contraction and sustained contraction.

active comparator: contribution of continence muscles motor function enhancement in improving fecal incontinence

Device: anorectal manometry/vaginal manometry (female) with c-RED Patients will then be assigned to one of the exercise protocols for 6 weeks. Protocol 1: 20 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 2: 40 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 3: 20 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 4: 40 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 5: 20 Kegel like repetitive short contractions without device Protocol 6: 40 Kegel like repetitive short contractions without device Protocol 7: 20 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned Protocol 8:40 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned

Interventions

continence muscles resistance device

The c-RED consists of a noncompliant cylindrical balloon (intra-anal balloon) that is connected to a small compliant balloon (external balloon) by a 2 mm diameter tube and a stopcock to allow for air to be filled and sealed in the system. The system is prefilled with air to determine the amount of air needed for a given internal pressure, or desired resistance of the intra-anal balloon. This is determined using a sphygmomanometer gauge in a sealed system.

Primary outcome measure

  • anal pressure [ Time Frame: during kegel like exercise ]
  • anal pressure [ Time Frame: after 6 weeks' exercise, during kegel like exercise ]
  • Vaginal pressure [ Time Frame: during kegel like exercise ]
  • Vaginal pressure [ Time Frame: after 6 weeks' exercise, during kegel like exercise ]
  • Fecal Incontinence severity [ Time Frame: before and after 6 weeks' exercise ]
  • Quality of life measure [ Time Frame: before and after 6 weeks' exercise ]

Central Contacts and Locations

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

Contacts

Ling Mei, MD

4148059694lmei@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • fecal incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-10-23.