Physical Therapy for Anal Incontinence
Primary Purpose
Anal Incontinence, Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Training
Concentric Training
Isometric Training
Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Anal Incontinence
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
Sites / Locations
- University of California San Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Eccentric Training
Concentric Training
Isometric Training
Biofeedback
Arm Description
Outcomes
Primary Outcome Measures
Change in Length Tension Manometry after 12 weeks
change from baseline to 12 weeks
Secondary Outcome Measures
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
change from baseline to 12 weeks
Change in FISI score after 12 weeks
change from baseline to 12 weeks
Full Information
NCT ID
NCT03252951
First Posted
August 14, 2017
Last Updated
October 24, 2022
Sponsor
San Diego State University
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT03252951
Brief Title
Physical Therapy for Anal Incontinence
Official Title
An Innovative Rehabilitation Approach for Women With Anal Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
University of California, San Diego
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Incontinence, Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eccentric Training
Arm Type
Experimental
Arm Title
Concentric Training
Arm Type
Experimental
Arm Title
Isometric Training
Arm Type
Experimental
Arm Title
Biofeedback
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Eccentric Training
Intervention Description
Different Anal Sphincter Exercise Types for muscle hypertrophy
Intervention Type
Behavioral
Intervention Name(s)
Concentric Training
Intervention Description
Different Anal Sphincter Exercise Types for muscle hypertrophy
Intervention Type
Behavioral
Intervention Name(s)
Isometric Training
Intervention Description
Different Anal Sphincter Exercise Types for muscle hypertrophy
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
Standard of Care Biofeedback Training
Primary Outcome Measure Information:
Title
Change in Length Tension Manometry after 12 weeks
Description
change from baseline to 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
Description
change from baseline to 12 weeks
Time Frame
12 weeks
Title
Change in FISI score after 12 weeks
Description
change from baseline to 12 weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Length Tension Manometry after 1 year
Description
change from baseline to 12 months
Time Frame
12 months
Title
Change in Length Tension Manometry after 2 years
Description
change from baseline to 24 months
Time Frame
24 months
Title
Change in Muscle Hypertrophy (ultrasound) after 1 year
Description
change from baseline to 12 months
Time Frame
12 months
Title
Change in Muscle Hypertrophy (ultrasound) after 2 years
Description
change from baseline to 24 months
Time Frame
24 months
Title
Change in FISI score after 1 year
Description
change from baseline to 12 months
Time Frame
12 months
Title
Change in FISI score after 2 years
Description
change from baseline to 24 months
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Tuttle, PT, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Therapy for Anal Incontinence
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