Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback

Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental

Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.

Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.

Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.

Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.

Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.

Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.

Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence; Outlet Dysfunction Constipation
• Intervention / Treatment: Behavioral: Biofeedback; Behavioral: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gloria Santaliestra; Email: gloria.santaliestra@vhir.org
• Study Contact Backup: Name: Jordi Serra, MD; Phone Number: 34 932746259; Email: jordi.serra@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Vall d'Hebron
    • Contact: Jordi Serra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Incontinence studies

• Patients who have at least 4 episodes of fecal incontinence during the last 14 days.
• Patients able to follow instructions and attend study visits.

Dyssinergic defecation studies

• Patients with constipation who present less than 3 complete spontaneous bowel movements per week and/or who have Bristol 1 or Bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study
• Patients able to follow instructions and attend study visits.

Exclusion Criteria:

• Patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer...
• Patients with neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease).
• Patients with previous of active colon and/or rectal cancer.
• Patients with rectal fistula.
• Patients with rectal prolapse.
• Patients with total colectomy.
• Patients who have had any radiation to the pelvis in the last month.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Behavioral: Placebo; Three visits will be made throughout the study following the same procedure as patients in the active arm. Patients randomized to placebo treatment will receive instructions to take a pill of placebo containing 0.3 g glucose daily at home. A final visit will be performed at the end of the study alike the active treatment group.
Experimental: Biofeedback	Behavioral: Biofeedback; Three visits will be made throughout the study. The first visit (Day -14) will consist of an evaluation of the inclusion criteria. A pre-treatment anorectal manometry will be performed, and a daily symptom questionnaire will be given to the patient. The second visit will take place 14 days later (Day 0). During this visit, the daily clinical symptom questionnaire will be collected and it will be verified that the patient meets the inclusion criteria. Patients who meet the criteria will be randomized 2:1 to active treatment or placebo. Patients will receive instructions, by means of psychoeducational videos on the exercises to be performed daily at home. A final visit will be performed at the end of the study (3 months in incontinence studies and 4 weeks in dyssynergic defecation studies). In incontinence study a final phone call will be performed at 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyssinergic defecation study: Number of bowel movements	Number and type (according to Bristol scale) of bowel movements during the last 15 days of study compared to the 15 days prior to treatment start.	4 weeks
Fecal incontinence study: Number of anal leaks	Number of involuntary leaks during the last 15 days of study compared to the 15 days prior to treatment start.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyssinergic defecation study: sensation of outlet obstructed evacuation	Frequency of the following sensations: sensation of anorectal obstruction/blockage; straining; incomplete evacuation; manual maneuvers to facilitate evacuation during the bowel movements produced during the last 15 days of study compared to the 15 days prior to treatment start using daily questionnaires.	4 weeks
Dyssinergic defecation study: Wexner scale	Score rated at the end of the study compared to the score rated prior to treatment start using the Wexner scale for constipation	4 weeks
Dyssinergic defecation study: Quality of life	Score rated at the end of the study compared to the score rated prior to treatment start using the patient assessment quality of life questionnaire for constipation (PACQoL)	4 weeks
Dyssinergic defecation study: anxiety and depression	Score rated at the end of the study compared to the score rated prior to treatment start using the hospital anxiety-depression questionnaire (HDA)	4 weeks
Dyssinergic defecation study: defecatory maneuvers	Abdominal contraction pressure and anal relaxation of the anal sphincters at the end of the study compared to pressures prior to treatment start measured by anorectal manometry	4 weeks
Incontinence study: Wexner scale	Score rated at the end of the study compared to the score rated prior to treatment start using the Wexner scale for incontinence.	3 and 6 months
Incontinence study: Quality of life	Score rated at the end of the study compared to the score rated prior to treatment start using the quality of life questionnaire for incontinence (FIQoL)	3 months
Incontinence study: anxiety and depression	Score rated at the end of the study compared to the score rated prior to treatment start using the hospital anxiety-depression questionnaire (HDA)	3 months
Incontinence study: Anal sphincter function	Resting pressure and squeeze pressure of the anal sphincters at the end of the study compared to pressures prior to treatment start measured by anorectal manometry	3 months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Jordi Serra, MD, University Hospital Vall d'Hebron

Publications and helpful links

General Publications

• Serra J, Pohl D, Azpiroz F, Chiarioni G, Ducrotte P, Gourcerol G, Hungin APS, Layer P, Mendive JM, Pfeifer J, Rogler G, Scott SM, Simren M, Whorwell P; Functional Constipation Guidelines Working Group. European society of neurogastroenterology and motility guidelines on functional constipation in adults. Neurogastroenterol Motil. 2020 Feb;32(2):e13762. doi: 10.1111/nmo.13762. Epub 2019 Nov 22.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): April 28, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Constipation; Fecal Incontinence
• Other Study ID Numbers: PR(AG)614/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No