Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

NCT02406859 | Completed Results DMC

• 2 other identifiers: B1915-PKOR-13-010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.

Conditions

Spinal Cord Injury; Constipation; Fecal Incontinence; Neurogenic Bowel

Keywords

Spinal Cord Injury; Constipation; Fecal Incontinence; Neurogenic Bowel; Bowel Biofeedback; Manometry

Outcome Measures

Primary Outcomes (1)

• Baseline Motility (Anorectal Sensation and Strength) Characteristics

  We aim to assess the following baseline motility characteristics: maximum sphincter pressure (resting and squeezing pressure), mean sphincter pressure, residual anal and intrarectal pressure (high pressure zone), and recto-anal pressure differential (difference of intrarectal and residual anal pressures) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.

  1 Session (Baseline Anorectal Manometry Assessment)

Secondary Outcomes (3)

• Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.

  Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

• Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.

  Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

• Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI

  Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

Study Arms (2)

Anorectal Manometry

EXPERIMENTAL

Part 1 \[Anorectal Manometry\]: Fifty SCI subjects and 15 AB subjects will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). Additional 10 able-bodied subjects will be enrolled to serve as controls. The 10 Question Bowel Survey and Incontinence Scale will be administered.

Behavioral: Anorectal Manometry

Bowel Biofeedback Training

EXPERIMENTAL

Part 2 \[Bowel Biofeedback\]: A subgroup of 20 subjects who participated in the first arm of the study (Anorectal Motility) and report either constipation or fecal incontinence will be asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry and bowel surveys will be repeated after the training session to assess the effects of bowel biofeedback on anorectal function.

Behavioral: Bowel Biofeedback

Interventions

Bowel Biofeedback BEHAVIORAL

Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks.

Bowel Biofeedback Training

Anorectal Manometry BEHAVIORAL

Subjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training.

Anorectal Manometry

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic SCI (duration over 1 year)
• Able-bodied (no SCI)

You may not qualify if:

• Contraindication to bowel biofeedback
• Currently pregnant or trying to become pregnant
• Inability to provide informed consent

Sponsors & Collaborators

• VA Office of Research and Development: lead
• James J. Peters Veterans Affairs Medical Center: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• Aloysius MM, Korsten MA, Radulovic M, Singh K, Lyons BL, Cummings T, Hobson J, Kahal S, Spungen AM, Bauman WA. Lack of improvement in anorectal manometry parameters after implementation of a pelvic floor/anal sphincter biofeedback in persons with motor-incomplete spinal cord injury. Neurogastroenterol Motil. 2023 Nov;35(11):e14667. doi: 10.1111/nmo.14667. Epub 2023 Sep 25.

  PMID: 37743783 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases

Limitations and Caveats

The trial was limited by a small number of participants due to strict inclusion and exclusion criteria

Results Point of Contact

• Title: Dr. Mark Korsten
• Organization: James J. Peters VAMC

mark.korsten@va.gov

718-741-4675

Study Officials

• Mark A Korsten, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: April 2, 2015
• Study Start: July 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: December 29, 2017
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)