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Clinical Trials/NCT06532123
NCT06532123RecruitingNot Applicable

Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease

Medical College of Wisconsin1 site in 1 country340 target enrollmentStarted: July 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
340
Locations
1
Primary Endpoint
anal pressure

Study Overview

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.

Detailed Description

To achieve the specific aim, the investigators will use state-of the-art available techniques and recording modalities, as well as a novel device that provides pre-determined different levels of resistance against contraction of continence muscles to induce measurable fatigue. The investigators will determine and characterize the fatigue characteristics of the striated continence muscles across adult age spectrum and sex. The investigators will determine and compare the effect of 6-weeks daily fatigue on continence musculature motor function and its effect on incontinence severity and related patient quality of life.

Aim1A: the investigators will determine and characterize the fatigue characteristics of the continence muscles induced by repetitive isotonic contractions using various loads, intervals, and repetitions in a. Continence muscle complex (comprised of external anal sphincter muscle group and puborectalis muscle) , and b. puborectalis muscle alone recorded intra-vaginally

Technique to induce fatigue: To apply resistance against contraction of continence muscles and to induce fatigue, the investigators developed a hand-made device in our laboratory; continence muscles resistance device; c-RED . The c-RED consists of a 6 cm x 2 cm noncompliant cylindrical balloon (intra-anal balloon) that is connected to a small compliant balloon (external balloon, about 1.5 x 2 cm) by a 2 mm diameter tube and a stopcock to allow for air to be filled and sealed in the system. To ensure consistent resistance provided by the anal balloon in the study, a commercially available noncompliant valvuloplasty balloon (Z-Med) is chosen to serve as the intra-anal balloon in the c-RED. 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. The intra-anal balloon, while providing resistance, is compressed by the anal contraction (exceeding the internal pressure) due to displacement of its air to the external distensible balloon. The compressibility of the anal balloon allows for the muscle shortening necessary for isotonic exercise. Air displacement into the external balloon results in its expansion allowing to maintain the predetermined intra-anal balloon pressure and serves as an externally visible indicator that an anal contraction has occurred. Using this device, the investigators can choose different level of resistance load on the continence muscles complex (external anal sphincters (EAS) and puborectalis muscle (PRM)).

High-resolution anorectal manometry: Anorectal manometric pressures will be monitored using a high-resolution anorectal manometry catheter (Medical Measurements Systems, Laborie) positioned across the anal canal with the distal end in the rectum. A computerized recording and analysis system stores pressure data from 8 sensor rows (23 pressure sensors total) spaced 1 cm apart along the probe.

High-resolution vaginal manometry: Vaginal pressure recording is a method to record contractile function of the puborectalis muscle. Reliable measurement of the pressure generated by PRM contraction from vaginal cavity has been challenging. However, using a combined technique of Barostat technology and high-resolution Manometry, the investigators have overcome this challenge.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: continence muscles resistance device (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

Intervention: continence muscles resistance device (Device)

Outcomes

Primary Outcomes

anal pressure

Time Frame: after 6 weeks' exercise, during kegel like exercise

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

Vaginal pressure

Time Frame: after 6 weeks' exercise, during kegel like exercise

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

Fecal Incontinence severity

Time Frame: before and after 6 weeks' exercise

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.

Quality of life measure

Time Frame: before and after 6 weeks' exercise

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.

anal pressure

Time Frame: during kegel like exercise

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

Vaginal pressure

Time Frame: during kegel like exercise

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ling Mei MD, MPH

Associate Professor

Medical College of Wisconsin

Study Sites (1)

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