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Clinical Trial NCT06273046 for Fecal Incontinence, Outlet Dysfunction Constipation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback 96 At-Home Randomized Exercise-Based
Clinical Trial NCT06273046 is an interventional study for Fecal Incontinence, Outlet Dysfunction Constipation that is recruiting. It started on April 17, 2024 with plans to enroll 96 participants. Led by Hospital Universitari Vall d'Hebron Research Institute, it is expected to complete by August 30, 2026. The latest data from ClinicalTrials.gov was last updated on July 6, 2025.
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 spe...
Show MoreOfficial Title
Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
Conditions
Fecal IncontinenceOutlet Dysfunction ConstipationPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- PR(AG)614/2023
NCT ID Number
Start Date (Actual)
2024-04-17
Last Update Posted
2025-07-06
Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
96
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBiofeedback | 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 pat...Show More |
Placebo ComparatorPlacebo | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
Hospital Universitari Vall d'Hebron Research InstituteStudy Central Contact
Contact: Jordi Serra, MD, 34 932746259, [email protected]
Contact: Gloria Santaliestra, [email protected]
1 Study Locations in 1 Countries
Hospital Vall d'Hebron, Barcelona, Spain
Jordi Serra, MD, Contact
Recruiting