Ongoing Clinical Trials for Anal Incontinence
There are currently 3 clinical trials investigating new treatments for anal incontinence. These studies are testing innovative approaches including stem cell therapies and botulinum toxin injections to help patients better control bowel movements and improve quality of life. Trials are taking place across multiple countries in Europe. (Also known as: Fecal Incontinence)
Clinical trial locations
- Austria
- Bulgaria
- Czechia
- France
- Germany
- Italy
- Poland
- Spain
- Sweden
Study on ICEF15 for Treating Fecal Incontinence in Patients with Anal Sphincter Dysfunction
This trial is testing a treatment called ICEF15, which uses special cells taken from a patient’s own skeletal muscles. These cells are then injected into the anal sphincter muscle to help restore control over bowel movements. The treatment is being compared against a placebo to determine its effectiveness.
Who can participate: Adults 18 years or older who have been experiencing urge-related bowel leakage for at least 6 months but not more than 10 years are eligible. Participants must have tried conservative treatments such as diet changes or pelvic floor exercises for at least 3 months without sufficient improvement. The incontinence episodes must occur more than twice weekly and be more than just traces. Additional requirements include specific muscle strength measurements and ultrasound results showing either an intact sphincter or limited damage.
Who cannot participate: People with bowel control problems caused by conditions other than external anal sphincter dysfunction are excluded. Those who cannot give informed consent, are participating in other trials, have had recent relevant surgeries, are pregnant or breastfeeding, or have allergies to the treatment components cannot join the study.
Study focus: The main goal is to see whether ICEF15 can reduce the frequency of incontinence episodes by at least 50% compared to before treatment. Participants will maintain a bowel diary throughout the study to track their symptoms. Regular follow-up visits will monitor progress and safety.
Investigational treatment: ICEF15 involves autologous skeletal muscle-derived cells that aim to regenerate and strengthen the weakened anal sphincter muscle, potentially improving bowel control.
Study on the Effects of Botulinum Toxin Type A and a Drug Combination on Rectal Function in Patients with Fecal Incontinence
This French study is investigating how botulinum toxin type A (commonly known as Botox) affects rectal function when injected directly into the rectum. The research aims to understand whether this treatment can improve bowel control in people with incontinence.
Who can participate: Adults at least 18 years old with active bowel incontinence that has not improved with first-line treatments like dietary changes or pelvic floor exercises are eligible. The condition must noticeably impact quality of life. Women of childbearing age must use effective contraception and have negative pregnancy tests. All participants must be affiliated with the French Social Security system and provide informed consent.
Who cannot participate: People with known allergies to botulinum toxin, neuromuscular disorders, recent rectal surgery, severe constipation, or active infections are excluded. Pregnant or breastfeeding women and those unable to follow study procedures cannot participate. Individuals already enrolled in another clinical trial are also excluded.
Study focus: Researchers will use a technique called high-resolution manometry to measure pressure and movement inside the rectum. The study will evaluate how botulinum toxin affects rectal contractions, the timing of these contractions, and overall quality of life. Laxatives will be used to stimulate bowel movements during testing.
Investigational treatment: Botulinum toxin is injected into the rectum and works by blocking certain nerve signals that cause muscle contractions, potentially helping to regulate bowel movements more effectively.
Study on the Safety and Effectiveness of Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells for Treating Fecal Incontinence in Patients
This Spanish trial is testing a regenerative medicine approach using stem cells derived from fat tissue. These cells are prepared in a special hyaluronic acid gel and injected into the affected area to help repair damaged sphincter muscles.
Who can participate: Men and women between 18 and 80 years old with a single sphincter defect not exceeding 140 degrees are eligible. Participants must have a severity score of at least 12 on the Wexner Test or experience at least 6 incontinence episodes over 21 days. The condition must have been present for at least one year. Both men and women must agree to use effective contraception throughout the study.
Who cannot participate: People without incontinence, those outside the specified age range, vulnerable populations who cannot make their own decisions, and those unwilling to follow study procedures are excluded. Individuals with other medical conditions that might interfere with the study cannot participate.
Study focus: The trial will test two different doses of stem cells (ALOFEC-60 and ALOFEC-120) against a placebo to determine which works best. Researchers will monitor changes in incontinence severity using the Jorge-Wexner test, track episodes through patient diaries, and measure quality of life. Additional testing includes anal manometry to measure muscle pressure and imaging techniques like 3D ultrasound to monitor tissue changes.
Investigational treatment: The adipose-derived mesenchymal stem cells are designed to promote tissue repair and regeneration in the damaged sphincter area. These cells can differentiate into various cell types and release growth factors that support healing.
Summary
Current research into anal incontinence treatments is exploring three distinct therapeutic approaches. Two studies focus on regenerative medicine using cell-based therapies—one using patients’ own muscle cells and another using stem cells from fat tissue. The third study investigates botulinum toxin injections to regulate rectal function.
Most trials are available across multiple European countries, with the ICEF15 study offering the widest access across nine countries including Austria, Bulgaria, Czechia, France, Germany, Italy, Poland, Spain, and Sweden. The botulinum toxin study is limited to France, while the stem cell therapy trial is conducted in Spain.
All three trials emphasize measuring quality of life improvements alongside clinical outcomes, recognizing the significant impact this condition has on daily activities and emotional well-being. Participants across all studies must have tried conventional treatments without success and are required to maintain detailed diaries to track their symptoms throughout the research period.