NCT03252951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

4.8 years

First QC Date

August 14, 2017

Last Update Submit

October 24, 2022

Conditions

Anal IncontinenceFecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Change in Length Tension Manometry after 12 weeks

    change from baseline to 12 weeks

    12 weeks

Secondary Outcomes (2)

  • Change in Muscle Hypertrophy (Ultrasound) after 12 weeks

    12 weeks

  • Change in FISI score after 12 weeks

    12 weeks

Other Outcomes (6)

  • Change in Length Tension Manometry after 1 year

    12 months

  • Change in Length Tension Manometry after 2 years

    24 months

  • Change in Muscle Hypertrophy (ultrasound) after 1 year

    12 months

  • +3 more other outcomes

Study Arms (4)

Eccentric Training

EXPERIMENTAL
Behavioral: Eccentric Training

Concentric Training

EXPERIMENTAL
Behavioral: Concentric Training

Isometric Training

EXPERIMENTAL
Behavioral: Isometric Training

Biofeedback

ACTIVE COMPARATOR
Behavioral: Biofeedback

Interventions

Eccentric TrainingBEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Eccentric Training
Concentric TrainingBEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Concentric Training
Isometric TrainingBEHAVIORAL

Different Anal Sphincter Exercise Types for muscle hypertrophy

Isometric Training
BiofeedbackBEHAVIORAL

Standard of Care Biofeedback Training

Biofeedback

Eligibility Criteria

Age22 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

San Diego, California, 92102, United States

Location

MeSH Terms

Conditions

EncopresisFecal Incontinence

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Lori Tuttle, PT, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 17, 2017

Study Start

September 1, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)