Physical Therapy for Anal Incontinence

An Innovative Rehabilitation Approach for Women With Anal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Anal Incontinence
• Intervention / Treatment: Behavioral: Eccentric Training; Behavioral: Concentric Training; Behavioral: Isometric Training; Behavioral: Biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92102
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eccentric Training	Behavioral: Eccentric Training; Different Anal Sphincter Exercise Types for muscle hypertrophy
Experimental: Concentric Training	Behavioral: Concentric Training; Different Anal Sphincter Exercise Types for muscle hypertrophy
Experimental: Isometric Training	Behavioral: Isometric Training; Different Anal Sphincter Exercise Types for muscle hypertrophy
Active Comparator: Biofeedback	Behavioral: Biofeedback; Standard of Care Biofeedback Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Length Tension Manometry after 12 weeks	change from baseline to 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks	change from baseline to 12 weeks	12 weeks
Change in FISI score after 12 weeks	change from baseline to 12 weeks	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Length Tension Manometry after 1 year	change from baseline to 12 months	12 months
Change in Length Tension Manometry after 2 years	change from baseline to 24 months	24 months
Change in Muscle Hypertrophy (ultrasound) after 1 year	change from baseline to 12 months	12 months
Change in Muscle Hypertrophy (ultrasound) after 2 years	change from baseline to 24 months	24 months
Change in FISI score after 1 year	change from baseline to 12 months	12 months
Change in FISI score after 2 years	change from baseline to 24 months	24 months

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Lori Tuttle, PT, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 141728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No