Neuromodulation for Bowel Incontinence

(TNT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Augusta University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called Translumbosacral Neuromodulation Therapy (TNT) for people with fecal incontinence (FI), especially women and elderly individuals. TNT uses magnetic pulses to stimulate nerves in the lower back, helping to improve control over bowel movements. The goal is to provide a more effective, non-invasive treatment option for those who struggle with FI.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on opioids, you cannot participate in the trial.

What data supports the idea that Neuromodulation for Bowel Incontinence is an effective treatment?

The available research shows that Translumbosacral Neuromodulation Therapy (TNT) can improve symptoms of bowel incontinence. One study found that TNT helps by affecting the communication between the gut and brain, which is important for controlling bowel movements. Another study looked at how often the treatment should be given and found it to be safe and effective in improving the condition. Additionally, other types of neuromodulation, like tibial nerve stimulation, have also shown success in treating bowel incontinence, suggesting that these therapies can be beneficial for patients. ^{1 2 3 4 5}

What safety data is available for neuromodulation therapy for bowel incontinence?

The safety of translumbosacral neuromodulation therapy (TNT) for fecal incontinence has been investigated in studies such as the 'Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial,' which aimed to assess the clinical effects and safety of TNT. Additionally, other forms of neuromodulation, like percutaneous tibial nerve stimulation, have been evaluated for safety in treating fecal incontinence, as seen in studies like 'Evaluation of the use of posterior tibial nerve stimulation for the treatment of fecal incontinence.' These studies suggest that neuromodulation therapies are generally considered safe, but specific safety data for TNT would be detailed in the individual study results. ^{1 2 3 4 6}

Is Translumbosacral Neuromodulation Therapy (TNT) a promising treatment for bowel incontinence?

Yes, Translumbosacral Neuromodulation Therapy (TNT) is a promising treatment for bowel incontinence. It has been shown to improve symptoms by potentially affecting the communication between the gut and brain, and enhancing the function of the muscles and nerves involved in bowel control. ^{1 2 3 4 7}

Research Team

Satish Rao, MD,PhD

Principal Investigator

Augusta University

Eligibility Criteria

This trial is for adults who've had bowel incontinence for at least 6 months, with weekly episodes. They must not have mucosal diseases, be on opioids, or have a range of other conditions like Crohn's disease, severe heart issues, metal implants near the treatment area, pacemakers, or certain past surgeries.

Inclusion Criteria

I have had at least one episode of incontinence per week.

No mucosal disease (colonoscopy + biopsy)

I have had recurring episodes of fecal incontinence for 6 months.

Exclusion Criteria

You are pregnant.

I have a condition where part of my rectum sticks out of my anus.

I have been diagnosed with either ulcerative colitis or Crohn's disease.

Treatment Details

Interventions

• Sham TNT Therapy (Other)
• Translumbosacral Neuromodulation Therapy (TNT) (Neuromodulation)

Trial Overview The study tests Translumbosacral Neuromodulation Therapy (TNT) against a sham (fake) therapy to see if TNT can improve bowel control by stimulating nerves with magnetic fields. It aims to find the best dose and understand how it works over short and long terms.

Participant Groups

Group I: 1 Hz 2400 TNT Treatment Active Control 1 Intervention

Intervention: TNT treatment intervention with 2400 total stimulations with the magnetic coil..

Group II: 1 Hz 3600 TNT Treatment Active Control 1 Intervention

Intervention: TNT treatment intervention with 3600 total stimulations with the magnetic coil.

Group III: Sham TNT Treatment Placebo Group 1 Intervention

This arm will have the sham treatment session. First we will assess the motor threshold intensity described above. Next, a sham coil is placed on each of 4 regions (2 lumbar \& 2 sacral), and 600 stimulations will be given at each site in 2 trains, with a 5 minutes rest period between each site and 3 minutes between trains.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Dr. David C. Hess

Augusta University

Chief Executive Officer since 2017

MD from Johns Hopkins University, Neurology residency and Vascular Neurology fellowship at Augusta University

Dr. David C. Hess

Augusta University

Chief Medical Officer since 2017

MD from University of Maryland School of Medicine

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

Translumbosacral neuromodulation therapy (TNT) significantly improves symptoms of fecal incontinence (FI) by enhancing afferent ano-cortical signaling and efferent motor pathways, particularly at a frequency of 1 Hz, as shown in a study with 33 participants.

The 1 Hz frequency not only decreased latencies in neural signaling but also increased anal sphincter pressure and maximum tolerable volume, leading to a higher rate of symptom improvement compared to other frequencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Translumbosacral Neuromodulation Therapy on Gut and Brain Interactions and Anorectal Neuropathy in Fecal Incontinence: A Randomized Study. Rao, SSC., Yan, Y., Xiang, X., et al.[2023]

In a study of 16 patients with severe fecal incontinence, percutaneous tibial nerve stimulation significantly improved fecal continence, with the Wexner score decreasing from 13.2 to 9 after the first treatment phase.

After six months without treatment, 5 out of 16 patients maintained good continence, indicating that the benefits of this minimally invasive therapy can be long-lasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the use of posterior tibial nerve stimulation for the treatment of fecal incontinence: preliminary results of a prospective study. de la Portilla, F., Rada, R., Vega, J., et al.[2019]

The NeuromOdulaTion for Accidental Bowel Leakage trial is designed to evaluate the effectiveness of percutaneous tibial nerve stimulation (PTNS) compared to a sham treatment in women with persistent fecal incontinence, involving 165 participants to ensure robust statistical power.

The study aims to provide high-level evidence on the efficacy of PTNS as a second-line treatment, with a focus on improving bowel control and quality of life over 12 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Zyczynski, HM., Arya, LA., Lukacz, ES., et al.[2022]

Sacral neuromodulation (SNM) is increasingly recognized as a promising treatment for neurogenic lower urinary tract dysfunction (NLUTD), particularly in patients with incomplete spinal cord injuries and multiple sclerosis, although most studies have methodological limitations and lack standardized success definitions.

Recent technological advancements aim to overcome barriers to SNM, such as MRI incompatibility and issues with the size and battery life of the implantable pulse generator, suggesting that this therapy could become more accessible and effective in the near future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction? Averbeck, MA., Moreno-Palacios, J., Aparicio, A.[2021]

Sacral neuromodulation (SNM) has shown a high success rate of 84.2% in treating neurogenic lower urinary tract dysfunctions (nLUTD) based on a meta-analysis of 24 studies involving 428 patients, indicating its effectiveness for these conditions.

The procedure is generally safe, with common adverse events occurring at low rates (e.g., 4.7% for loss of effectiveness and 3.6% for infection), but the authors note the need for more rigorous studies to confirm these findings and address limitations in the current research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years' Experience and Future Directions. van Ophoven, A., Engelberg, S., Lilley, H., et al.[2021]

In a study of 20 patients with refractory fecal incontinence, percutaneous tibial nerve stimulation did not significantly improve incontinence scores after treatment, indicating limited efficacy for this therapy.

However, 68.4% of patients who subsequently received sacral nerve stimulation reported significant improvement in their incontinence scores, suggesting that sacral nerve stimulation is an effective second-line treatment for those who do not respond to tibial nerve stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of sacral nerve stimulation for fecal incontinence in patients refractory to percutaneous tibial nerve stimulation. Hotouras, A., Murphy, J., Thin, NN., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Translumbosacral Neuromodulation Therapy on Gut and Brain Interactions and Anorectal Neuropathy in Fecal Incontinence: A Randomized Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the use of posterior tibial nerve stimulation for the treatment of fecal incontinence: preliminary results of a prospective study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Is there a role for sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years' Experience and Future Directions. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Outcome of sacral nerve stimulation for fecal incontinence in patients refractory to percutaneous tibial nerve stimulation. [2022]