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ViewAttendees 1

Session:: ePosters-Sun350-M3: Pelvic Floor

EP640 - A Novel Laser Treatment of Fecal Incontinence - A First-In-Human Safety & Feasibility study

Sunday, May 10, 2026
3:55 PM - 4:00 PM ET

    ePoster Presenter(s)

  • Yaron Rudnicki, MD (he/him/his)

    Head of Colorectal Surgery Unit
    Meir Medical Center
    Meir Medical Center
    Kfar Saba, Tel Aviv, Israel

    Disclosure information not submitted.

    View ePoster

    • Author(s)

  • RA

    Rotem Amir Keret, MD

    Colorectal Surgeon
    Meir Medical Center
    Kfar Saba, HaMerkaz, Israel

    Disclosure information not submitted.

  • HS

    Hagai Soback, MD

    General Surgery Resident
    Meir Medical Center
    ramat hasharon, HaMerkaz, Israel

    Disclosure information not submitted.

  • SA

    Shmuel Avital, Prof.

    Chief of Surgery
    Meir Medical Center
    Kefar Sava, HaMerkaz, Israel

    Disclosure information not submitted.

    • Senior Author(s)

  • YR

    Yehuda Ringel, Prof.

    Chief of the Gastroenterology and Hepatology Division
    Meir Medical Center
    Kefar Sava, HaMerkaz, Israel

    Disclosure information not submitted.

Purpose/Background: The pathophysiology of fecal incontinence (FI) is multifactorial and often involves weakness of the anal sphincter muscles. Infrared laser-based thermotherapy elicits rapid, localized, gentle heating, which triggers healing processes, including neo-collagen deposition and tissue thickening. Following a successful proof-of-concept preclinical study in a porcine model that demonstrated promising results, a first-in-human (FIH) clinical study was performed to evaluate the safety and feasibility of the technique in patients with FI and to explore its potential clinical effects.

Methods/Interventions: A prospective, open-label, clinical study in patients who met the Rome IV criteria for FI and decreased anal sphincter pressure. Patients underwent 4-6 sessions of trans-anal thermotherapy using 1470nm diode laser illumination of 250J, 5 minutes per session, every 4 weeks. Patients were evaluated pre- and post-treatment using home diaries, clinical questionnaires including the Wexner FI score, physical examination, high-resolution anorectal manometry (HRM), and trans-rectal ultrasound (TRUS).

Results/Outcomes: Eight females with severe FI, ages 61-78, were treated with 4-6 Laser treatments each (42 total treatments). All procedures were successfully completed. No serious adverse events, mucosal injuries, or major patient discomfort were reported. Seven patients (88%) responded to the treatment, defined by improvement by two points or more in the Wexner FI score (Fig. 1). Overall, five patients (63%) reported a reduction in FI episodes from 1-3 events per day to 0-3 events per month, with most no longer requiring use of pads. This clinical improvement was associated with an increase in mean resting anal pressures, from 45.3 ± 3.1 mmHg pre-treatment to 48.6 ± 2.8 mmHg post-treatment.

Conclusion/Discussion: Treating Fecal Incontinence with a 1470nm diode laser illumination is feasible, safe, and well-tolerated. This treatment may have a significant beneficial clinical effect and impact on patients' well-being. Our laser illumination therapy of the internal anal sphincter appears to increase anal sphincter continence without jeopardizing or harming adjacent tissues. A multi-center large efficacy trial is underway.

Figure 1
Wexner score fecal incontinence improvement after 4-6 laser treatments.