Mechanisms of Improving Fecal Continence Muscles Motor Function

NCT06532123 | Recruiting FDA Device

• 1 other identifier: PRO00052310
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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

Keywords

fecal incontinence

Outcome Measures

Primary Outcomes (6)

• anal pressure

  Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral

  during kegel like exercise

• anal pressure

  Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral

  after 6 weeks' exercise, during kegel like exercise

• Vaginal pressure

  Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral

  during kegel like exercise

• Vaginal pressure

  Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral

  after 6 weeks' exercise, during kegel like exercise

• Fecal Incontinence severity

  Vaizey Incontinence Score to quantify the severity of fecal incontinence. The Vaizey score is a validated tool and consists of two scoring systems with a five-point scale, which evaluates type and frequency of solid/liquid stool loss, flatus incontinence and impact on quality of life. Vaizey score ranges from 0 to 24, with 0 indicating perfect continent and 24 suggesting complete incontinence.

  before and after 6 weeks' exercise

• Quality of life measure

  The investigators will use Fecal Incontinence Quality of Life scale (FIQOL).FIQOL is used to evaluate psychometric health-related quality of life parameters in fecal incontinence patients. The score is arranged on four psychosocial scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment, and contains a total of 29 different items. Subscale scores range from 1 to 5 and are the average response to all items on the scale.

  before and after 6 weeks' exercise

Study Arms (2)

fatigability of various striated continence muscles healthy adults

ACTIVE COMPARATOR

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.

Device: continence muscles resistance device

contribution of continence muscles motor function enhancement in improving fecal incontinence

ACTIVE COMPARATOR

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

Device: continence muscles resistance device

Interventions

continence muscles resistance device 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.

contribution of continence muscles motor function enhancement in improving fecal incontinence; fatigability of various striated continence muscles healthy adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

RECRUITING

Related Publications (2)

• Mei L, Patel K, Lehal N, Kern MK, Benjamin A, Sanvanson P, Shaker R. Fatigability of the external anal sphincter muscles using a novel strength training resistance exercise device. Am J Physiol Gastrointest Liver Physiol. 2021 Apr 1;320(4):G609-G616. doi: 10.1152/ajpgi.00456.2020. Epub 2021 Feb 17.

  PMID: 33596155 BACKGROUND

• Patel K, Mei L, Yu E, Kern M, Lehal N, Edeani F, Sanvanson P, Davidson ERW, Shaker R. Differences in fatigability of muscles involved in fecal continence: Potential clinical ramifications. Physiol Rep. 2021 Dec;9(24):e15144. doi: 10.14814/phy2.15144.

  PMID: 34927399 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: to characterize fatigue characteristic of various continence muscles and to determine the relative/individual contribution of striated continence muscles, including Puborectalis muscle (PRM) and External anal sphincter (EAS) motor function enhancement in improving fecal incontinence.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 15, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)