10 - Translumbosacral Neuromodulation Therapy Reverses Neuropathy in Patients With Fecal Incontinence

Award: ACG Outstanding Research Award in the Functional Bowel Disease Category (Trainee)

Karlo Fidel, MD¹, Yun Yan, PA-C¹, Jenna Clukey, MS², Kyle Staller, MD, MPH², Braden Kuo, MD³, Shaheen Hamdy, MD⁴, Deepak Ayyala, MR¹, Satish SC. Rao, MD, PhD, FACG¹
1Augusta University Medical Center, Augusta, GA; 2Massachusetts General Hospital, Boston, MA; 3Center for Neurointestinal Health, Massachusetts General Hospital, Boston, MA; 4The University of Manchester, Manchester, England, United Kingdom

Introduction: Fecal incontinence (FI) is a multifactorial problem that includes neuropathic dysfunction, which has been poorly investigated or treated. Translumbosacral Neuromodulation Therapy (TNT) is a novel, non-invasive treatment that targets lumbosacral neuropathy and may improve FI.

Aim: To investigate whether TNT improves lumbosacral neuropathy in patients with FI.

Methods: 109 patients (23 male, 86 female, mean age = 64.3) with ≥1 FI episode/week were enrolled in a multi-center, randomized, sham-controlled trial. Lumbosacral Motor-Evoked Potentials (MEP) were assessed at 4 sites (8 MEP's) using Translumbosacral Anorectal Magnetic Stimulation (TAMS) test (nerve conduction) at baseline and 6 weeks by placing a 4-sensor MEP probe in the anorectum. Patients received either active TNT (2400 OR 3600 magnetic stimulation) or sham (2400 stimulations) at right and left lumbar and right and left sacral sites with 1Hz, weekly for six weeks.

Results: After TNT, all 8 nerve conduction MEP latencies in the 3600 group and 6/8 sites in the 2400 group significantly improved (p≤0.02) and normalized when compared to the sham group and baseline. There was no change in the sham group (Table 1). Mean FI episodes improved significantly (p< .001) in the active TNT groups with a higher responder rate (p< .001) compared to sham (Table 2).

Discussion: Patients with FI demonstrate significant bilateral lumbar and sacral plexus neuropathy confirming that anorectal neuropathy is a key pathophysiological dysfunction in FI patients. TNT significantly improved the underlying neuropathy particularly those affecting the anal nerves. TNT is an effective and safe treatment that reverses neuropathy in FI patients and thereby improves FI symptoms. Acknowledgement: This study was supported by NIDDK R01DK121003.


Figure: TABLE 1. Motor Evoked Potentials at Baseline and after TNT Treatment


Figure: Table 2. FI Episodes and Responder Rates

Disclosures:
Karlo Fidel indicated no relevant financial relationships.
Yun Yan indicated no relevant financial relationships.
Jenna Clukey indicated no relevant financial relationships.
Kyle Staller: Ardelyx – Grant/Research Support. Gemelli – Consultant. Laborie – Consultant. Mahana – Consultant. Salix – Consultant. Takeda – Expert witness.
Braden Kuo: Atmo – Consultant. Cindome – Consultant. ClinRx Pharma – Consultant. Evoke – Consultant. Genzynme – Consultant. GI Foundation – Consultant. Ironwood – Consultant. Medtronic – Consultant. Neurogastrx – Consultant. Novo – Consultant. Phathom – Consultant. Takeda – Consultant.
Shaheen Hamdy indicated no relevant financial relationships.
Deepak Ayyala indicated no relevant financial relationships.
Satish Rao: Laborie Medical Technologies – Grant/Research Support. Vibrant Ltd – Advisory Committee/Board Member.

Karlo Fidel, MD¹, Yun Yan, PA-C¹, Jenna Clukey, MS², Kyle Staller, MD, MPH², Braden Kuo, MD³, Shaheen Hamdy, MD⁴, Deepak Ayyala, MR¹, Satish SC. Rao, MD, PhD, FACG¹, 10, Translumbosacral Neuromodulation Therapy Reverses Neuropathy in Patients With Fecal Incontinence, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.