rTMS for Overactive Bladder

(TMS_OAB Trial)

Overseen By Michelle Almarez, BBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Wellbutrin, others

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a non-invasive treatment called repetitive transcranial magnetic stimulation (rTMS) to assist individuals with overactive bladder (OAB). OAB can disrupt daily life, causing frequent bathroom trips and sudden urges to urinate. The treatment uses magnetic pulses to stimulate specific brain areas, potentially improving bladder control and quality of life. Individuals who have experienced OAB symptoms for at least three months and frequent urges to urinate may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options for OAB.

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 prior data suggests that rTMS is safe for treating overactive bladder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated. Studies have found rTMS to be safe for various conditions, including in older adults and those with memory or cognitive issues. In research on rTMS for overactive bladder (OAB) and similar conditions, no major side effects were reported. rTMS is non-invasive, meaning it doesn't involve surgery or entering the body. However, individual experiences can vary. Participants in those studies noted improvements in bladder function with minimal discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rTMS (repetitive Transcranial Magnetic Stimulation) for treating overactive bladder because it offers a non-invasive approach that targets brain areas linked to bladder control. Unlike current treatments, which often involve medications or invasive procedures, rTMS uses magnetic fields to stimulate specific regions of the brain, like the supplemental motor area and prefrontal cortex. This technique could provide a new way to manage symptoms without the side effects associated with drugs or the recovery time needed for surgical options.

What evidence suggests that rTMS is effective for overactive bladder?

Research shows that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, might help with symptoms of an overactive bladder (OAB). Studies have found that rTMS can increase bladder capacity, potentially reducing feelings of urgency. In people with urinary problems after a stroke, 4 weeks of rTMS improved several aspects of urinary incontinence. Evidence also indicates that it can lessen symptoms in people with Parkinson's disease by increasing their bladder capacity. While these findings are promising, more research is needed to fully understand how rTMS works for OAB. ^{1 6 7 8 9}

Who Is on the Research Team?

Michelle Almarez, BBA

Principal Investigator

Houston Methodist Obstetrics & Gynecology Department

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

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.

How Is the Trial Designed?

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)

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

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A randomized controlled trial of low-frequency repeated ...

Our data confirmed that 4 weeks of LF-rTMS stimulation on the contralateral M1 positively affects poststroke urinary incontinence in several aspects.

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The primary and secondary outcomes will be urinary incontinence severity and quality of life evaluated using the Overactive Bladder Symptom Score and ...

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It has been reported that LF rTMS is able to reverse low urinary tract disturbances in patients with PD [22], enhancing bladder capacity and the ...

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In the literature, it is suggested that rTMS improves symptoms in the storage phase, increases detrusor pressure during voiding, and reduces ...

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Transcranial magnetic stimulation and biofeedback improved bladder function in patients with multiple sclerosis. These approaches have a high level of safety ...