Using fat injections to treat fecal incontinence

AUTOGRAFI : Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial

This study is testing whether injecting fat into the anal area can help people with severe fecal incontinence feel better when other treatments haven't worked.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (other)
• Locations: 3 sites (Angers and 2 other locations)
• Trial ID: NCT04972799 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of injecting autologous fat into the intersphincter space for patients suffering from severe fecal incontinence. Participants will receive either the fat injection or a saline placebo in a randomized, double-blind, crossover design, allowing for direct comparison of outcomes. The study aims to address the limitations of current treatment options, particularly for those who have not responded to rehabilitation or neuromodulation therapies. By assessing the impact on fecal incontinence episodes and sphincter function, the trial seeks to provide new therapeutic insights.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe fecal incontinence who have not benefited from other management strategies.

Not a fit: Patients with contraindications to general anesthesia or those with significant pelvic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from severe fecal incontinence.

How similar studies have performed: Preliminary studies have shown some improvement with autologous fat injections in related conditions, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 18 years of age or older
2. severe fecal incontinence characterized by at least one episode of weekly fecal incontinence
3. failed rehabilitation and dietary management strategies
4. who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence)
5. having, for women of childbearing age, effective contraception throughout the study
6. having given free, informed and written consent

Exclusion Criteria:

1. unable or unwilling to undergo follow-up or symptomatic evaluation
2. contraindication to general anesthesia
3. contraindication to metronidazole (hypersensitivity and wheat allergy)
4. significant pelvic static disorder
5. active anal suppuration
6. anal stenosis
7. externalized rectal prolapse
8. chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
9. on anticoagulants or antiaggregants
10. history of anal or rectal neoplasia
11. coagulation anomaly, curative anticoagulation
12. history of rectal surgery
13. history of pelvic radiotherapy
14. previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion
15. allergy to lidocaine or contraindication to adrenaline
16. protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor)
17. participating in another interventional trial concurrently
18. not covered by a social security system

Where this trial is running

Angers and 2 other locations

• CHU Angers — Angers, France (NOT_YET_RECRUITING)
• CHU Nantes — Nantes, France (NOT_YET_RECRUITING)
• CHU Rennes — Rennes, France (RECRUITING)

Study contacts

• Principal investigator: Brochard Charlène — Rennes University Hospital
• Study coordinator: Mevel Nicolas

Conditions: Fecal Incontinence, Autograft