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Physical Therapy for Anal Incontinence

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ClinicalTrials.gov Identifier: NCT03252951
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Lori Tuttle, San Diego State University

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.

Condition or disease Intervention/treatment Phase
Anal Incontinence Fecal Incontinence Behavioral: Eccentric Training Behavioral: Concentric Training Behavioral: Isometric Training Behavioral: Biofeedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Innovative Rehabilitation Approach for Women With Anal Incontinence
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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




Primary Outcome Measures :
  1. Change in Length Tension Manometry after 12 weeks [ Time Frame: 12 weeks ]
    change from baseline to 12 weeks


Secondary Outcome Measures :
  1. Change in Muscle Hypertrophy (Ultrasound) after 12 weeks [ Time Frame: 12 weeks ]
    change from baseline to 12 weeks

  2. Change in FISI score after 12 weeks [ Time Frame: 12 weeks ]
    change from baseline to 12 weeks


Other Outcome Measures:
  1. Change in Length Tension Manometry after 1 year [ Time Frame: 12 months ]
    change from baseline to 12 months

  2. Change in Length Tension Manometry after 2 years [ Time Frame: 24 months ]
    change from baseline to 24 months

  3. Change in Muscle Hypertrophy (ultrasound) after 1 year [ Time Frame: 12 months ]
    change from baseline to 12 months

  4. Change in Muscle Hypertrophy (ultrasound) after 2 years [ Time Frame: 24 months ]
    change from baseline to 24 months

  5. Change in FISI score after 1 year [ Time Frame: 12 months ]
    change from baseline to 12 months

  6. Change in FISI score after 2 years [ Time Frame: 24 months ]
    change from baseline to 24 months



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252951


Contacts
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Contact: Lori Tuttle, PT, PhD 6195941918 ltuttle@mail.sdsu.edu

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92102
Contact: Lori Tuttle, PT, PhD       ltuttle@sdsu.edu   
Sponsors and Collaborators
San Diego State University
University of California, San Diego
Investigators
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Principal Investigator: Lori Tuttle, PT, PhD San Diego State University

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Responsible Party: Lori Tuttle, Associate Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT03252951     History of Changes
Other Study ID Numbers: 141728
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases