What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuromodulation technique used to treat conditions like overactive bladder (OAB), which is related to Urge Incontinence. The known side effects of rTMS are generally mild and include headaches, scalp discomfort at the stimulation site, and, rarely, seizures. Other common treatments for Urge Incontinence, such as anticholinergic medications, can cause dry mouth, constipation, blurred vision, and cognitive dysfunction, particularly in elderly patients. Beta3-adrenoceptor agonists like mirabegron may cause hypertension, nasopharyngitis, and urinary tract infections. Overall, rTMS is considered safe with fewer systemic side effects compared to pharmacological treatments.

What prior FDA approvals exist?

FDA-approved treatments for Urge Incontinence primarily include antimuscarinic agents such as oxybutynin, tolterodine, and solifenacin, which work by relaxing the bladder muscle. Beta-3 adrenergic agonists like mirabegron are also approved and function by relaxing the bladder muscle to increase its storage capacity. While rTMS is being studied for its potential benefits in normalizing brain activity related to overactive bladder symptoms, it is not yet an FDA-approved treatment for Urge Incontinence. Current treatments focus on pharmacological approaches rather than neuromodulation techniques like rTMS.

What other types of research exist?

Promising novel alternatives to rTMS for treating urge incontinence include percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS). Both methods have shown efficacy in managing overactive bladder symptoms, including urge incontinence, through neuromodulation. Additionally, pharmacotherapy with agents like solifenacin succinate and mirabegron has demonstrated effectiveness in clinical trials for overactive bladder, which can include urge incontinence.

← Back to Search

Neuromodulation

rTMS for Overactive Bladder (TMS_OAB Trial)

N/A

Recruiting

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females & Males 40 to 80 years old

Be older than 18 years old

Must not have

Personal or immediate family history of seizure disorder, Taking (bupropion) Wellbutrin or heavy alcohol use, Parkinson's disease, Multiple sclerosis, spinal cord injury, Intracranial lesions and hemorrhagic stroke within the last 12 months, History of interstitial cystitis, pelvic radiation, bladder augmentation, Intradetrusor botulinum toxin injections within 6 months, Pelvic floor therapy within 2 months, Active/on-mode Sacral nerve stimulator (eligible if turned off), Incarcerated patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention at: 1 day, 3 weeks, 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for this trial aren't detailed, rTMS is generally considered safe and has been used safely in elderly populations and those with cognitive impairments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention at: 1 day, 3 weeks, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention at: 1 day, 3 weeks, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention at: 1 day, 3 weeks, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional connectivity

Regional brain activity

Secondary study objectives

OAB Symptom Bother

OAB related Quality of life

Pelvic floor muscle activity

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcranial magnetic stimulationExperimental Treatment1 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Urge Incontinence include antimuscarinic agents, beta-3 adrenergic agonists, and neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS). Antimuscarinic agents work by blocking muscarinic receptors in the bladder, reducing involuntary contractions. Beta-3 adrenergic agonists relax the bladder muscle by stimulating beta-3 adrenergic receptors. Neuromodulation techniques, such as rTMS, aim to normalize brain activity and improve bladder control by modulating neural circuits involved in bladder function. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific condition, potentially improving efficacy and reducing side effects.