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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273046
• Other study ID #: PR(AG)614/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Jordi Serra, MD
• Phone: 34 932746259
• Email: jordi.serra[@]vallhebron.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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