Physical Therapy for Anal Incontinence

October 24, 2022 updated by: Lori Tuttle, San Diego State University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Length Tension Manometry after 12 weeks
Time Frame: 12 weeks
change from baseline to 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Muscle Hypertrophy (Ultrasound) after 12 weeks
Time Frame: 12 weeks
change from baseline to 12 weeks
12 weeks
Change in FISI score after 12 weeks
Time Frame: 12 weeks
change from baseline to 12 weeks
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Length Tension Manometry after 1 year
Time Frame: 12 months
change from baseline to 12 months
12 months
Change in Length Tension Manometry after 2 years
Time Frame: 24 months
change from baseline to 24 months
24 months
Change in Muscle Hypertrophy (ultrasound) after 1 year
Time Frame: 12 months
change from baseline to 12 months
12 months
Change in Muscle Hypertrophy (ultrasound) after 2 years
Time Frame: 24 months
change from baseline to 24 months
24 months
Change in FISI score after 1 year
Time Frame: 12 months
change from baseline to 12 months
12 months
Change in FISI score after 2 years
Time Frame: 24 months
change from baseline to 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
San Diego State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lori Tuttle, PT, PhD, San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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