Clinical trial NCT06273046: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback
Official title: Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Incontinence
Outlet Dysfunction Constipation
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fecal incontinence study: Number of anal leaks
timeFrame: 3 months
measure: Dyssinergic defecation study: Number of bowel movements
timeFrame: 4 weeks
Secondary outcomes:
measure: Incontinence study: Wexner scale
timeFrame: 3 and 6 months
measure: Incontinence study: Quality of life
timeFrame: 3 months
measure: Incontinence study: anxiety and depression
timeFrame: 3 months
measure: Incontinence study: Anal sphincter function
timeFrame: 3 months
measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation
timeFrame: 4 weeks
measure: Dyssinergic defecation study: Wexner scale
timeFrame: 4 weeks
measure: Dyssinergic defecation study: Quality of life
timeFrame: 4 weeks
measure: Dyssinergic defecation study: anxiety and depression
timeFrame: 4 weeks
measure: Dyssinergic defecation study: defecatory maneuvers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: University Hospital Vall d'Hebron
name: Jordi Serra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.