An interventional study of Biofeedback and Placebo in Fecal Incontinence and Outlet Dysfunction Constipation, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's planned enrollment of 96 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Incontinence studies
Dyssinergic defecation studies
Exclusion Criteria:
Behavioral: Biofeedback
Behavioral: Placebo
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.
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.
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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 3 months
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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 4 weeks
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Hospital Universitari Vall d'Hebron Research Institute