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NCT Number: NCT06273046

Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Outlet Dysfunction Constipation Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron

Barcelona, Spain

Location status: Recruiting

Location contact

Jordi Serra, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback

Behavioral

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.

Placebo

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Incontinence study: Wexner scale

    Time frame: 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.

  2. Incontinence study: Quality of life

    Time frame: 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)

  3. Incontinence study: anxiety and depression

    Time frame: 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)

  4. Incontinence study: Anal sphincter function

    Time frame: 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

  5. Dyssinergic defecation study: sensation of outlet obstructed evacuation

    Time frame: 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.

  6. Dyssinergic defecation study: Wexner scale

    Time frame: 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

  7. Dyssinergic defecation study: Quality of life

    Time frame: 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)

  8. Dyssinergic defecation study: anxiety and depression

    Time frame: 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)

  9. Dyssinergic defecation study: defecatory maneuvers

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Santaliestra

CONTACT

[email protected]

Jordi Serra, MD

CONTACT

[email protected]

34 932746259

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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