Fecal IncontinenceNCT06273046
Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback
A study testing Biofeedback in people with Fecal Incontinence and Outlet Dysfunction Constipation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Incontinence, Outlet Dysfunction Constipation
- What is being tested?
- Biofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gloria Santaliestra contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona
Jordi Serra, MD
About this study
Official title: Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
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.
Read more
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.
- Being tested
- Biofeedback, Placebo
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
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.
PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Not described Receives: Behavioral: Biofeedback |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (9)
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start17 Apr 2024
- Primary completion30 Apr 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordi Serra, MD, Principal investigator, University Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273046
- Sponsor's protocol ID
- PR(AG)614/2023
- Status last verified
- Jul 2025
- First submitted
- 15 Feb 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31756783
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental
- ClinicalTrials.gov ID
- NCT06273046
- Acronym / sponsor ID
- PR(AG)614/2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Biofeedback |
| Placebo | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackThree 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. | Behavioural | Biofeedback |
| PlaceboThree 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. | Behavioural | Placebo |
Primary outcome
Fecal incontinence study: Number of anal leaks
Time frame: 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
Time frame: 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.
9 secondary outcomes
Incontinence study: Wexner scale
Time frame: 3 and 6 months
Incontinence study: Quality of life
Time frame: 3 months
Incontinence study: anxiety and depression
Time frame: 3 months
Incontinence study: Anal sphincter function
Time frame: 3 months
Dyssinergic defecation study: sensation of outlet obstructed evacuation
Time frame: 4 weeks
Dyssinergic defecation study: Wexner scale
Time frame: 4 weeks
Dyssinergic defecation study: Quality of life
Time frame: 4 weeks
Dyssinergic defecation study: anxiety and depression
Time frame: 4 weeks
Dyssinergic defecation study: defecatory maneuvers
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 31756783Serra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gloria Santaliestra contact
Jordi Serra, MD principal investigator
University Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Fecal Incontinence and Outlet Dysfunction Constipation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordi Serra, MD (34 932746259, jordi.serra@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal incontinence study: Number of anal leaks (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.