Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback
- Conditions
- Outlet Dysfunction ConstipationFecal Incontinence
- Interventions
- Behavioral: PlaceboBehavioral: Biofeedback
- Registration Number
- NCT06273046
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Biofeedback Biofeedback -
- Primary Outcome Measures
Name Time Method Fecal incontinence study: Number of anal leaks 3 months Number of involuntary leaks during the last 15 days of study compared to the 15 days prior to treatment start.
Dyssinergic defecation study: Number of bowel movements 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Incontinence study: Quality of life 3 months 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)
Incontinence study: Anal sphincter function 3 months 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
Dyssinergic defecation study: Quality of life 4 weeks 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)
Dyssinergic defecation study: sensation of outlet obstructed evacuation 4 weeks 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.
Incontinence study: anxiety and depression 3 months Score rated at the end of the study compared to the score rated prior to treatment start using the hospital anxiety-depression questionnaire (HDA)
Dyssinergic defecation study: Wexner scale 4 weeks Score rated at the end of the study compared to the score rated prior to treatment start using the Wexner scale for constipation
Dyssinergic defecation study: anxiety and depression 4 weeks Score rated at the end of the study compared to the score rated prior to treatment start using the hospital anxiety-depression questionnaire (HDA)
Incontinence study: Wexner scale 3 and 6 months Score rated at the end of the study compared to the score rated prior to treatment start using the Wexner scale for incontinence.
Dyssinergic defecation study: defecatory maneuvers 4 weeks 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
Trial Locations
- Locations (1)
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain