Physical Therapy for Anal Incontinence

NCT ID: NCT03252951

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Anal Incontinence; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eccentric Training

Group Type: EXPERIMENTAL

Eccentric Training

Intervention Type: BEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Concentric Training

Group Type: EXPERIMENTAL

Concentric Training

Intervention Type: BEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Isometric Training

Group Type: EXPERIMENTAL

Isometric Training

Intervention Type: BEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Biofeedback

Group Type: ACTIVE_COMPARATOR

Biofeedback

Intervention Type: BEHAVIORAL

Standard of Care Biofeedback Training

Interventions

Eccentric Training

Different Anal Sphincter Exercise Types for muscle hypertrophy

Intervention Type: BEHAVIORAL

Concentric Training

Different Anal Sphincter Exercise Types for muscle hypertrophy

Intervention Type: BEHAVIORAL

Isometric Training

Different Anal Sphincter Exercise Types for muscle hypertrophy

Intervention Type: BEHAVIORAL

Biofeedback

Standard of Care Biofeedback Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• AI based on FISI questionnaire
• FISI scores between 10 and 45
• able to voluntarily contract pelvic floor muscles based on manometry measures

Exclusion Criteria

• FISI score below 10 (mild disease) or greater than 45 (severe disease)
• manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
• history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
• constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
• large pelvic organ prolapse (greater than stage 3)
• inability to contract the pelvic floor muscles on command
• pregnancy

• Minimum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Lori Tuttle

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori Tuttle, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

University of California San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

141728

Identifier Type: -

Identifier Source: org_study_id