Fecal IncontinenceTNTNCT03899181
Translumbosacral Neuromodulation for FI
A study testing Translumbosacral Neuromodulation Therapy (TNT) in people with Fecal Incontinence, run by Augusta University at 2 sites in United States.
Trial summary
Fecal Incontinence (FI) affects 40 million Americans, predominantly women and elderly. It is a major health care burden, significantly impairs quality of life and psychosocial function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Translumbosacral Neuromodulation Therapy (TNT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2019to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent episodes of FI for 6 months;
- No mucosal disease (colonoscopy + biopsy); and
- On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
Who cannot join
- severe diarrhea (>6 liquid stools/day, Bristol scale >6);
- on opioids,);
- active depression;
- severe cardiac disease, chronic renal failure or previous GI surgery except cholecystectomy and appendectomy;
- neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury) and increased intracranial pressure;
- metal implants (within 30 cm of magnetic coil placement), pacemakers;
Show all 11Show fewer
- previous pelvic surgery/radiation, radical hysterectomy;
- Ulcerative and Crohn's colitis;
- rectal prolapse;
- active anal fissure, anal abscess, congenital anorectal malformation, fistulae or inflamed hemorrhoids;
- pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912-4810
Satish Rao, MD, PhD, 706-721-2238, srao@augusta.edu
Tennekoon Karunaratne, MD,PhD, +1-706-721-1968, tkarunaratne@augusta.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Ahmad Samad, 617-726-2132, ASAMAD1@mgh.harvard.edu
Kyle Staller, MD, +1-617-724-6038, KSTALLER@mgh.harvard.edu
About this study
Official title: Translumbosacral Neuromodulation Therapy For Fecal Incontinence: Randomized Trial
Fecal Incontinence (FI) affects 40 million Americans, predominantly women and elderly. It is a major health care burden, significantly impairs quality of life and psychosocial function. FI is characterized by multifactorial dysfunction including lumbosacral neuropathy, anorectal sensori-motor dysfunction, and abnormal pelvic floor-brain innervation. A critical barrier to progress in the treatment of FI is the lack of RCTs, absence of mechanistically based non-invasive therapies that modify disease, and a lack of understanding on how treatments affect pathophysiology of FI. Consequently, most current remedies remain ineffective. Our long-term goal is to address the problem of lack of effective treatments for FI by investigating treatments that modulate neuronal perturbations and thereby improve sensory and motor control, and to understand the neurobiologic basis of these treatments. Our central hypothesis is that a novel, non-invasive treatment consisting of Translumbosacral Neuromodulation Therapy (TNT), using repetitive magnetic stimulation, will significantly improve FI in the short-term and long-term, by enhancing neural excitability and inducing neuroplasticity. Our approach is based on compelling pilot study which showed that TNT at 1 Hz frequency, significantly improved FI, by enhancing bidirectional gut- brain signaling, anal sphincter strength and rectal sensation compared to 5 or 15 Hz. Our objectives are to 1) investigate the efficacy, safety and optimal dose of a new treatment, TNT, in a sham controlled, randomized dose-dependent study in 132 FI patients; 2) determine the mechanistic basis for TNT by assessing the efferent and afferent pelvic floor-brain signaling, and sensori-motor function; 3) identify the durability of treatment response and effects of TNT, and whether reinforcement TNT provides augmented improvement, by performing a long-term, sham controlled randomized trial. Our expected outcomes include the demonstration of TNT as a durable, efficacious, safe, mechanistically based, non-invasive, and low risk treatment for FI. The impact of our project includes a novel, disease modifying, non-invasive treatment, a scientific basis for this treatment, and improved understanding of the pathophysiology of FI and how TNT modifies bidirectional gut and brain axes and anorectal function. Ultimately, the knowledge generated by this project will provide new avenues for the development of innovative, evidence-based therapies for FI.
Read the detailed description
Fecal incontinence (FI), defined as the involuntary passage of either formed or liquid stool, affects 8-15% of ambulatory Americans, mostly women and elderly and 45% of nursing home residents. It occurs at least weekly in 3% of adults, and in 37% of patients attending primary care clinics. FI has a major impact on quality of life, causes significant distress including anxiety and depression, and carries a considerable health care burden. FI is characterized by multifactorial dysfunctions that include lumbosacral neuropathy, anorectal sensori-motor dysfunction, and decreased rectosigmoid reservoir capacity and maladaptive pelvic floor-brain innervation. Consequently, treatments that help a single dysfunction, for example, anal dextranomer injection or anal sphincteroplasty could improve FI by reinforcing the anal barrier, but unlikely to improve the multidimensional problem of FI. Also, anal sphincteroplasty felt to be effective initially, was disappointing long-term with only 30% remaining continent at 10 years. An-other surgical procedure, sacral nerve stimulation (SNS) has been shown to be useful in 54% of FI patients, but has significant complications (33%) and a failure rate of 15%, its mechanism of action is unknown, and lacks rigorous sham-controlled trial. Furthermore, a comparative assessment of the effectiveness of current treatments has not been performed, and none of the current therapies have been shown to improve the multifactorial pathophysiological dysfunction(s) in FI.
A critical barrier to progress in the treatment of FI is the lack of RCTs, and absence of mechanistically based non-invasive therapies that modify the pathophysiology of FI. Consequently, most current remedies have remained ineffective. These findings were highlighted by experts at a recent NIDDK workshop focused on research in FI. Our long-term goal is to address the problem of lack of effective treatments for FI by investigating therapies that modulate peripheral and central neuronal perturbations, and to understand the neurobiologic basis of these treatments. Translumbosacral Neuromodulation Therapy (TNT) is a novel, non-invasive technique that involves the focal delivery of magnetic energy through an insulated coil to the lumbo-sacral nerves that regulate anorectal function. The pulses generated are of the same strength as clin-ical MRI machines. It builds on the concept of neuromodulation therapies such as repetitive transcranial magnetic stimulation (rTMS) that uses a computerized electromechanical medical device to deliver brief pulses of magnetic energy and has been shown to be effective in major depression , refractory auditory hallucinations (AH), and visceral pain, and our studies in post-stroke dysphagia. Our central hypothesis is that TNT will significantly improve FI, both in the short-term and long-term, by enhancing neural excitability and inducing neuroplasticity, and thereby will provide a multidimensional thera-peutic benefit- improve neuropathy, enhance anal strength, improve rectal perception and capacity.
- Conditions
- Fecal Incontinence
- Being tested
- Translumbosacral Neuromodulation Therapy (TNT), Sham TNT Therapy
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translumbosacral Neuromodulation Therapy (TNT)Device
A probe with 2 pairs of bipolar steel ring electrodes, will be placed in the rectum. At each site a mapping procedure is performed with single stimulus coil to assess the motor threshold intensity, defined as the minimum level of magnetic stimulation intensity required to achieve an anal and rectal MEP response of 10 microvolts and an anterior tibialis MEP of 20 microvolts with 50% of trials.The intensity for TNT at each site is capped at a maximum of 150% above this threshold to comply with safety guidelines. Thus, intensity of magnetic stimulations will be individualized. Bilateral lumbar stimulations (rTLMS) are administered at L2/L3 disc space, and sacral stimulations (rTSMS) at S2/S3 level. Next a 70 mm double air film self-cooling coil is positioned randomly over one of the 4 sites, held in place by a coil fixator and 300 or 450 stimulations are delivered. After a 5 min rest the cycle is repeated (Total =600-900/site).The coil is moved to the opposite side and it is repeated.
Sham TNT TherapyOther
This is the sham TNT treatment as mentioned in the different ARMs using the fake coil with no magnetic stimulations.
| Study group | Role | What they receive |
|---|---|---|
| 1 Hz 2400 TNT Treatment | Active comparator | Intervention: TNT treatment intervention with 2400 total stimulations with the magnetic coil.. Receives: Device: Translumbosacral Neuromodulation Therapy (TNT) |
| 1 Hz 3600 TNT Treatment | Active comparator | Intervention: TNT treatment intervention with 3600 total stimulations with the magnetic coil. Receives: Device: Translumbosacral Neuromodulation Therapy (TNT) |
| Sham TNT Treatment | Sham comparator | 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. Receives: Other: Sham TNT Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIM 1 Primary Outcome measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 6 weeks compared to baseline.
A responder will be defined as a patient who shows at least 50% reduction in FI episodes/week when compared to baseline.
Measured: 6 weeks (short term)
AIM 2: Latencies for lumbo-anal Magnetic Evoked Potentials (MEP) responses compared to baseline
The bilateral latencies, amplitudes and area under the curve (AUC) for the lumbo-anal MEP responses will be measured.
Measured: 6 weeks
AIM 2: Latencies for sacro-anal MEP responses compared to baseline
The bilateral latencies, amplitudes and area under the curve (AUC) for the sacro-anal MEP responses will be measured.
Measured: 6 weeks
AIM 2: Latencies for the ano-cortical Cortical Evoked Potentials (CEP) responsecompared to baseline.
The bilateral latencies, amplitudes and area under the curve (AUC) for the anal CEPs will be averaged to measure the latency of each component, P1, N2, etc, and mean group data.
Measured: 6 weeks
AIM 3:Primary Outcome measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 48 weeks compared to baseline.
A responder will be defined as a patient who shows > 50% reduction in FI episodes/week at the end of 48 weeks compared to baseline
Measured: 48 weeks (long term)
AIM 3: Latencies for lumbo-anal MEP responses
The bilateral latencies, amplitudes and area under the curve (AUC) for the lumbo-anal MEP responses will be measured.
Measured: 48 weeks
AIM 3: Latencies for sacro-anal MEP responses
The bilateral latencies, amplitudes and area under the curve (AUC) for the sacro-anal MEP responses will be measured.
Measured: 48 weeks
AIM 3: Latencies for the ano-cortical CEP response .
The bilateral latencies, amplitudes and area under the curve (AUC) for the anal CEPs will be averaged to measure the latency of each component, P1, N2, etc, and mean group data
Measured: 48 weeks
Secondary outcomes (27)
Stool Frequency
Stool frequency-how often subjects have a bowel movement.
Measured: 6 weeks, 48 weeks
Stool consistency
Stool consistency (Bristol Stool scale, 1-7). 1-very hard stool, 4-normal, smooth stool, and 7-watery stool
Measured: 6 weeks, 48 weeks
Bowel Urgency
Severity of Bowel urgency-Unable to postpone BM for more than 15 Minutes? YES/NO
Measured: 6 weeks, 48 weeks
Reduction of Fecal Incontinence (FI) episodes
Percentage of subjects with 100% and 75% reduction in FI episodes compared to baseline
Measured: 6 weeks, 48 weeks
Stool Leakage Characteristics
Leakage characteristics-amount 0. None
- Mild
- Moderate
- Excessive
Measured: 6 weeks, 48 weeks
Global Assessment of bowel satisfaction
using 7 point Likert scale (1. Considerably relieved; 7-considerably worse)
Measured: 6 weeks,, 48 weeks
Global Assessment of bowel satisfaction-Visual Analog Scale
0 (absent)-10 (very severe) point visual analog scale (VAS)
Measured: 6 weeks, 48 weeks
FI severity-Fecal Incontinence Severity Index (FISI)
Fecal Incontinence Severity Index (FISI)-assessed on characteristics of accidental bowel leakage: 1: 2 or More times a day and 6: Never any symptom
Measured: 6 weeks,4 8 weeks
FI severity-Fecal Incontinence Severity Score (FISS):
Fecal Incontinence Severity Score (FISS): 5 questions asking about severity of their fecal incontinence. Not a scale.
Measured: 6 weeks, 48 weeks
FI severity-International Consultation on Incontinence Questionnaire (IC-IQB):
International Consultation on Incontinence Questionnaire (IC-IQB): Questionnaire asking several questions about bowel symptoms. There are scales within each question: 0: never-4:always. How much does this (symptom) bother you? 0 (not at all) and 10 (a great deal).
Measured: 6 weeks, 48 weeks
Change in FI Quality of Life (FI-QOL)
A 4 question questionnaire that assesses the quality of life with FI symptoms. 2 questions have scaled questions: 1 (most of the time) 4 (none of the time) and 1(strongly agree) 4 (Strongly disagree)
Measured: 6 weeks, 48 weeks
Psychological Function PROMIS anxiety Questionnaire
Questionnaire that assesses anxiety symptoms. Asks questions on a scale of 1 (never) and 5 (always).
Measured: 6 weeks, 48 weeks
Psychological Function PROMIS Depression Questionnaire
Questionnaire that assesses Depression symptoms. Asks questions on a scale of 1 (never) and 5 (always).
Measured: 6 weeks, 48 weeks
Psychological Function PROMIS Efficacy Questionnaire
Questionnaire that assesses self-efficacy for managing symptoms. Asks questions on a scale of 1 (I am not at all confident) and 5 (I am very confident).
Measured: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for lumbo-rectal MEP compared to baseline
of the lumbo-rectal MEP responses.
Measured: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for sacro-rectal MEP
Milivolts of the nerve for the sacral-rectal MEP compared to baseline.
Measured: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for recto-cortical CEP responses
Milivolts of the nerve for the recto-cortical CEP responses compared to baseline.
Measured: 6 weeks, 48 weeks
MEP Index The area under the curve of the MEP response
The area under the curve of the MEP response compared to baseline
Measured: 6 weeks, 48 weeks
Anal Sphincter Function-Sustained Squeeze Pressure
Anal sustained squeeze pressure (mm Hg) measure from Anal rectal manometry study compared to baseline.
Measured: 6 weeks, 48 weeks
Anal Sphincter Function-Anal Resting Pressure
Anal resting pressure (mm Hg) measure from Anal rectal manometry study compared to baseline.
Measured: 6 weeks, 48 weeks
Anal Sphincter Function-Squeeze Pressure
Anal squeeze pressure (mm Hg) measure from Anal rectal manometry study.
Measured: 6 weeks, 48 weeks
Rectal Sensation-First Sensation (volume of air)
During anal manometry test, subject tells investigator when they feel a first sensation of the balloon inside their rectum. (measure in mL of air).
Measured: 6 weeks, 48 weeks
Rectal Sensation- Desire to defecate
During anal manometry test, subject tells investigator when they feel a desire to defecate from the balloon that is blown up inside their rectum. (measure in mL of air).
Measured: 6 weeks, 48 weeks
Rectal Sensation-Urgency to Defecate
During anal manometry test, subject tells investigator when they feel an urgency to defecate from the balloon that is blown up inside their rectum. (measure in mL of air).
Measured: 6 weeks, 48 weeks
Rectal Sensation-Maximum tolerable volume
During anal manometry test, subject tells investigator when they feel have a maximum tolerable volume (as much as they can handle) from the balloon that is blown up inside their rectum. (measure in mL of air).
Measured: 6 weeks, 48 weeks
Rectal Compliance
Assessed by dv/dp
Measured: 6 weeks, 48 weeks
Symptoms correlation
Correlate bowel symptoms (FI episodes), severity and physiological changes with MEP and CEP latency.
Measured: 6 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start5 Jun 2019
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Satish Rao, Augusta University
- Investigators
- Satish Rao, MD,PhD, Study director, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899181
- Sponsor's protocol ID
- 1303352
- Other IDs
- R01DK121003
- Acronym
- TNT
- Status last verified
- Jul 2022
- First submitted
- 20 Feb 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rao SSC, Yan Y, Hamdy S, Staller K, Fidel K, Aziz A, Sharma A, Clukey J, Ayyala D, Kuo B. Randomized Sham-Controlled Trial of Translumbosacral Neuromodulation Therapy for Fecal Incontinence. Gastroenterology. 2026 May 7:S0016-5085(26)06828-9. doi: 10.1053/j.gastro.2026.04.027. Online ahead of print.
PubMed 42105947
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translumbosacral Neuromodulation Therapy For Fecal Incontinence: Randomized Trial
- ClinicalTrials.gov ID
- NCT03899181
- Acronym / sponsor ID
- TNT / 1303352
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fecal Incontinence (FI) affects 40 million Americans, predominantly women and elderly. It is a major health care burden, significantly impairs quality of life and psychosocial function. FI is characterized by multifactorial dysfunction including lumbosacral neuropathy, anorectal sensori-motor dysfunction, and abnormal pelvic floor-brain innervation. A critical barrier to progress in the treatment of FI is the lack of RCTs, absence of mechanistically based non-invasive therapies that modify disease, and a lack of understanding on how treatments affect pathophysiology of FI. Consequently, most current remedies remain ineffective. Our long-term goal is to address the problem of lack of effective treatments for FI by investigating treatments that modulate neuronal perturbations and thereby improve sensory and motor control, and to understand the neurobiologic basis of these treatments. Our central hypothesis is that a novel, non-invasive treatment consisting of Translumbosacral Neuromodulation Therapy (TNT), using repetitive magnetic stimulation, will significantly improve FI in the short-term and long-term, by enhancing neural excitability and inducing neuroplasticity. Our approach is based on compelling pilot study which showed that TNT at 1 Hz frequency, significantly improved FI, by enhancing bidirectional gut- brain signaling, anal sphincter strength and rectal sensation compared to 5 or 15 Hz. Our objectives are to 1) investigate the efficacy, safety and optimal dose of a new treatment, TNT, in a sham controlled, randomized dose-dependent study in 132 FI patients; 2) determine the mechanistic basis for TNT by assessing the efferent and afferent pelvic floor-brain signaling, and sensori-motor function; 3) identify the durability of treatment response and effects of TNT, and whether reinforcement TNT provides augmented improvement, by performing a long-term, sham controlled randomized trial. Our expected outcomes include the demonstration of TNT as a durable, efficacious, safe, mechanistically based, non-invasive, and low risk treatment for FI. The impact of our project includes a novel, disease modifying, non-invasive treatment, a scientific basis for this treatment, and improved understanding of the pathophysiology of FI and how TNT modifies bidirectional gut and brain axes and anorectal function. Ultimately, the knowledge generated by this project will provide new avenues for the development of innovative, evidence-based therapies for FI.
Detailed description
Fecal incontinence (FI), defined as the involuntary passage of either formed or liquid stool, affects 8-15% of ambulatory Americans, mostly women and elderly and 45% of nursing home residents. It occurs at least weekly in 3% of adults, and in 37% of patients attending primary care clinics. FI has a major impact on quality of life, causes significant distress including anxiety and depression, and carries a considerable health care burden. FI is characterized by multifactorial dysfunctions that include lumbosacral neuropathy, anorectal sensori-motor dysfunction, and decreased rectosigmoid reservoir capacity and maladaptive pelvic floor-brain innervation. Consequently, treatments that help a single dysfunction, for example, anal dextranomer injection or anal sphincteroplasty could improve FI by reinforcing the anal barrier, but unlikely to improve the multidimensional problem of FI. Also, anal sphincteroplasty felt to be effective initially, was disappointing long-term with only 30% remaining continent at 10 years. An-other surgical procedure, sacral nerve stimulation (SNS) has been shown to be useful in 54% of FI patients, but has significant complications (33%) and a failure rate of 15%, its mechanism of action is unknown, and lacks rigorous sham-controlled trial. Furthermore, a comparative assessment of the effectiveness of current treatments has not been performed, and none of the current therapies have been shown to improve the multifactorial pathophysiological dysfunction(s) in FI.
A critical barrier to progress in the treatment of FI is the lack of RCTs, and absence of mechanistically based non-invasive therapies that modify the pathophysiology of FI. Consequently, most current remedies have remained ineffective. These findings were highlighted by experts at a recent NIDDK workshop focused on research in FI. Our long-term goal is to address the problem of lack of effective treatments for FI by investigating therapies that modulate peripheral and central neuronal perturbations, and to understand the neurobiologic basis of these treatments. Translumbosacral Neuromodulation Therapy (TNT) is a novel, non-invasive technique that involves the focal delivery of magnetic energy through an insulated coil to the lumbo-sacral nerves that regulate anorectal function. The pulses generated are of the same strength as clin-ical MRI machines. It builds on the concept of neuromodulation therapies such as repetitive transcranial magnetic stimulation (rTMS) that uses a computerized electromechanical medical device to deliver brief pulses of magnetic energy and has been shown to be effective in major depression , refractory auditory hallucinations (AH), and visceral pain, and our studies in post-stroke dysphagia. Our central hypothesis is that TNT will significantly improve FI, both in the short-term and long-term, by enhancing neural excitability and inducing neuroplasticity, and thereby will provide a multidimensional thera-peutic benefit- improve neuropathy, enhance anal strength, improve rectal perception and capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Hz 2400 TNT Treatment | Active comparator | Device: Translumbosacral Neuromodulation Therapy (TNT)Intervention: TNT treatment intervention with 2400 total stimulations with the magnetic coil.. |
| 1 Hz 3600 TNT Treatment | Active comparator | Device: Translumbosacral Neuromodulation Therapy (TNT)Intervention: TNT treatment intervention with 3600 total stimulations with the magnetic coil. |
| Sham TNT Treatment | Sham comparator | Other: Sham TNT TherapyThis 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent episodes of FI for 6 months;
- No mucosal disease (colonoscopy + biopsy); and
- On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
Key exclusion criteria (11 listed)
- severe diarrhea (>6 liquid stools/day, Bristol scale >6);
- on opioids,);
- active depression;
- severe cardiac disease, chronic renal failure or previous GI surgery except cholecystectomy and appendectomy;
- neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury) and increased intracranial pressure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translumbosacral Neuromodulation Therapy (TNT)A probe with 2 pairs of bipolar steel ring electrodes, will be placed in the rectum. At each site a mapping procedure is performed with single stimulus coil to assess the motor threshold intensity, defined as the minimum level of magnetic stimulation intensity required to achieve an anal and rectal MEP response of 10 microvolts and an anterior tibialis MEP of 20 microvolts with 50% of trials.The intensity for TNT at each site is capped at a maximum of 150% above this threshold to comply with safety guidelines. Thus, intensity of magnetic stimulations will be individualized. Bilateral lumbar stimulations (rTLMS) are administered at L2/L3 disc space, and sacral stimulations (rTSMS) at S2/S3 level. Next a 70 mm double air film self-cooling coil is positioned randomly over one of the 4 sites, held in place by a coil fixator and 300 or 450 stimulations are delivered. After a 5 min rest the cycle is repeated (Total =600-900/site).The coil is moved to the opposite side and it is repeated. | Device | 1 Hz 2400 TNT Treatment, 1 Hz 3600 TNT Treatment |
| Sham TNT TherapyThis is the sham TNT treatment as mentioned in the different ARMs using the fake coil with no magnetic stimulations. | Other | Sham TNT Treatment |
Primary outcome
AIM 1 Primary Outcome measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 6 weeks compared to baseline.
Time frame: 6 weeks (short term)
A responder will be defined as a patient who shows at least 50% reduction in FI episodes/week when compared to baseline.
AIM 2: Latencies for lumbo-anal Magnetic Evoked Potentials (MEP) responses compared to baseline
Time frame: 6 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the lumbo-anal MEP responses will be measured.
AIM 2: Latencies for sacro-anal MEP responses compared to baseline
Time frame: 6 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the sacro-anal MEP responses will be measured.
AIM 2: Latencies for the ano-cortical Cortical Evoked Potentials (CEP) responsecompared to baseline.
Time frame: 6 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the anal CEPs will be averaged to measure the latency of each component, P1, N2, etc, and mean group data.
AIM 3:Primary Outcome measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 48 weeks compared to baseline.
Time frame: 48 weeks (long term)
A responder will be defined as a patient who shows > 50% reduction in FI episodes/week at the end of 48 weeks compared to baseline
AIM 3: Latencies for lumbo-anal MEP responses
Time frame: 48 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the lumbo-anal MEP responses will be measured.
AIM 3: Latencies for sacro-anal MEP responses
Time frame: 48 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the sacro-anal MEP responses will be measured.
AIM 3: Latencies for the ano-cortical CEP response .
Time frame: 48 weeks
The bilateral latencies, amplitudes and area under the curve (AUC) for the anal CEPs will be averaged to measure the latency of each component, P1, N2, etc, and mean group data
27 secondary outcomes
Stool Frequency
Time frame: 6 weeks, 48 weeks
Stool consistency
Time frame: 6 weeks, 48 weeks
Bowel Urgency
Time frame: 6 weeks, 48 weeks
Reduction of Fecal Incontinence (FI) episodes
Time frame: 6 weeks, 48 weeks
Stool Leakage Characteristics
Time frame: 6 weeks, 48 weeks
Global Assessment of bowel satisfaction
Time frame: 6 weeks,, 48 weeks
Global Assessment of bowel satisfaction-Visual Analog Scale
Time frame: 6 weeks, 48 weeks
FI severity-Fecal Incontinence Severity Index (FISI)
Time frame: 6 weeks,4 8 weeks
FI severity-Fecal Incontinence Severity Score (FISS):
Time frame: 6 weeks, 48 weeks
FI severity-International Consultation on Incontinence Questionnaire (IC-IQB):
Time frame: 6 weeks, 48 weeks
Change in FI Quality of Life (FI-QOL)
Time frame: 6 weeks, 48 weeks
Psychological Function PROMIS anxiety Questionnaire
Time frame: 6 weeks, 48 weeks
Psychological Function PROMIS Depression Questionnaire
Time frame: 6 weeks, 48 weeks
Psychological Function PROMIS Efficacy Questionnaire
Time frame: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for lumbo-rectal MEP compared to baseline
Time frame: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for sacro-rectal MEP
Time frame: 6 weeks, 48 weeks
Amplitudes (Milivolts of the nerve) for recto-cortical CEP responses
Time frame: 6 weeks, 48 weeks
MEP Index The area under the curve of the MEP response
Time frame: 6 weeks, 48 weeks
Anal Sphincter Function-Sustained Squeeze Pressure
Time frame: 6 weeks, 48 weeks
Anal Sphincter Function-Anal Resting Pressure
Time frame: 6 weeks, 48 weeks
Anal Sphincter Function-Squeeze Pressure
Time frame: 6 weeks, 48 weeks
Rectal Sensation-First Sensation (volume of air)
Time frame: 6 weeks, 48 weeks
Rectal Sensation- Desire to defecate
Time frame: 6 weeks, 48 weeks
Rectal Sensation-Urgency to Defecate
Time frame: 6 weeks, 48 weeks
Rectal Sensation-Maximum tolerable volume
Time frame: 6 weeks, 48 weeks
Rectal Compliance
Time frame: 6 weeks, 48 weeks
Symptoms correlation
Time frame: 6 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 42105947Rao SSC, Yan Y, Hamdy S, Staller K, Fidel K, Aziz A, Sharma A, Clukey J, Ayyala D, Kuo B. Randomized Sham-Controlled Trial of Translumbosacral Neuromodulation Therapy for Fecal Incontinence. Gastroenterology. 2026 May 7:S0016-5085(26)06828-9. doi: 10.1053/j.gastro.2026.04.027. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish Rao, MD,PhD study director
Augusta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translumbosacral Neuromodulation Therapy (TNT) in people with Fecal Incontinence, run by Augusta University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satish Rao, MD, PhD (7067212238, srao@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIM 1 Primary Outcome measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 6 weeks compared to baseline. (time frame: 6 weeks (short term)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.