rTMS for Overactive Bladder

(TMS_OAB Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Wellbutrin, others

Disqualifiers: Pregnancy, Seizure disorder, Parkinson's, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a non-invasive treatment with magnetic fields to help adults with overactive bladder. The magnetic pulses aim to normalize brain activity and improve bladder control. The study will measure changes in symptoms and brain activity over time.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Wellbutrin (bupropion).

What data supports the effectiveness of the treatment rTMS for Overactive Bladder?

Research shows that rTMS (repetitive transcranial magnetic stimulation) can improve bladder function in conditions like multiple sclerosis and Parkinson's disease, where it helps with urinary symptoms by enhancing bladder capacity and reducing symptoms. This suggests that rTMS might also be helpful for overactive bladder by improving bladder control. ^{1 2 3 4 5}

Is rTMS safe for treating overactive bladder?

Repetitive Transcranial Magnetic Stimulation (rTMS) has been studied for various conditions, including bladder issues in Parkinson's disease and multiple sclerosis, and is generally considered safe. It is a noninvasive treatment that has shown temporary improvements in bladder function without significant safety concerns reported in these studies. ^{1 2 3 4 6}

How is the treatment rTMS unique for overactive bladder?

rTMS (Repetitive Transcranial Magnetic Stimulation) is unique for treating overactive bladder because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, potentially improving bladder function by enhancing neural pathways involved in bladder control. Unlike traditional medications, rTMS targets the brain directly, which may offer relief for those who do not respond well to standard drug therapies. ^{1 2 3 5 6}

Research Team

Michelle Almarez, BBA

Principal Investigator

Houston Methodist Obstetrics & Gynecology Department

Eligibility Criteria

This trial is for adults with overactive bladder (OAB), which may include symptoms like urinary incontinence, bedwetting, and urge incontinence. Participants should be experiencing a significant impact on their quality of life due to OAB. The eligibility criteria are not fully listed here.

Inclusion Criteria

I am between 40 and 80 years old.

I have had overactive bladder symptoms for 3 months without a current UTI.

Bladder diary: Mean voids/24 hours ≥ 8.0, Mean urgency episodes/24 hours ≥ 3.0, Montreal Cognitive Assessment (MoCA) score >10

Exclusion Criteria

Pregnant, nursing, or self-report of planning to become pregnant

Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual

Qmax < 10 ml/s in males on uroflow, < 20th percentile on Liverpool nomogram, Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation with questionnaires, clinical data, and fMRI to assess brain activity during urinary urgency

1 week

1 visit (in-person)

Treatment

Participants receive 5 daily sessions of rTMS targeting the supplemental motor area and prefrontal cortex

1 week

5 visits (in-person)

Post-intervention Evaluation

Evaluation with questionnaires, clinical data, and fMRI is repeated to assess changes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of OAB symptoms and quality of life

6 weeks

3 visits (in-person or virtual)

Treatment Details

Interventions

• rTMS (Neuromodulation)

Trial Overview The study is testing the use of repetitive transcranial magnetic stimulation (rTMS) as a non-invasive treatment for OAB. rTMS aims to normalize brain activity that could be linked to OAB symptoms. This trial will also explore changes in the brain and how they relate to improvements in symptoms.

Participant Groups

Group I: Transcranial magnetic stimulation Experimental Treatment 1 Intervention

All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation)

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Dr. John P. Cooke

The Methodist Hospital Research Institute

Chief Medical Officer since 2013

MD, PhD

Dr. Jenny Chang

The Methodist Hospital Research Institute

Chief Executive Officer

MBBChir from University of Cambridge, MHCM from Johns Hopkins University

Findings from Research

In a study involving multiple sclerosis (MS) patients with lower urinary tract symptoms, 5-Hz repetitive transcranial magnetic stimulation (rTMS) applied over the motor cortex for five consecutive days improved the voiding phase of urination.

The results suggest that increasing excitability in the corticospinal tract may help improve bladder function by enhancing detrusor contraction and urethral sphincter relaxation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. Centonze, D., Petta, F., Versace, V., et al.[2022]

A 2-week course of low frequency 1 Hz repetitive transcranial magnetic stimulation (rTMS) improved urinary tract function in 8 advanced Parkinson's disease patients, increasing bladder capacity and the sensation of filling.

Patients reported a significant reduction in urinary symptoms, as measured by the International Prostate Symptoms Score (IPSS), with benefits lasting up to 2 weeks after treatment, suggesting rTMS is a promising noninvasive option for managing urinary disturbances in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inhibitory rTMS on bladder function in Parkinson's disease patients. Brusa, L., Finazzi Agrò, E., Petta, F., et al.[2022]

In a study involving 15 patients with Bladder Pain Syndrome/Interstitial Cystitis, repetitive Transcranial Magnetic Stimulation (rTMS) significantly reduced chronic pelvic pain and improved urinary symptoms compared to sham treatment.

rTMS was found to enhance quality of life without any serious adverse events, indicating it is a safe and effective adjunct therapy for patients whose pain does not respond to standard drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis. Cervigni, M., Onesti, E., Ceccanti, M., et al.[2019]

A randomized controlled trial is set to evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (rTMS) on the primary motor cortex for treating poststroke urinary incontinence, involving 140 patients over 20 treatment sessions.

The primary outcome will assess changes in urodynamic tests after 4 weeks, with secondary outcomes including urinary incontinence questionnaires and pelvic floor muscle function, aiming to provide high-quality evidence for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial. Jiang, W., Tang, W., Song, Y., et al.[2022]

Motor evoked potentials (MEPs) may be a useful tool for investigating urologic disorders, but their clinical applicability is limited due to poor reproducibility in pelvic floor muscle assessments.

Repetitive transcranial magnetic stimulation (rTMS) shows promise in improving bladder function in patients with neurogenic bladder dysfunction, particularly in conditions like multiple sclerosis and Parkinson's disease, suggesting it could help restore sphincter function after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and bladder function: A systematic review. Nardone, R., Versace, V., Sebastianelli, L., et al.[2020]

A 68-year-old woman with bladder pain syndrome experienced complete relief from suprapubic pain and a 60-80% reduction in micturition frequency after 16 sessions of high-intensity, low-frequency rTMS targeting the dorsolateral prefrontal cortex.

This study is the first to demonstrate that rTMS can effectively alleviate symptoms of bladder pain syndrome, improving not only pain and urinary symptoms but also overall quality of life and daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Relief of Painful Bladder Syndrome by High-Intensity, Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right and Left Dorsolateral Prefrontal Cortices. Nizard, J., Esnault, J., Bouche, B., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. [2022]

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

Effects of inhibitory rTMS on bladder function in Parkinson's disease patients. [2022]

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

Repetitive transcranial magnetic stimulation for chronic neuropathic pain in patients with bladder pain syndrome/interstitial cystitis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and bladder function: A systematic review. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Relief of Painful Bladder Syndrome by High-Intensity, Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right and Left Dorsolateral Prefrontal Cortices. [2020]