rTMS in Overactive Bladder

NCT ID: NCT06198439

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-07-31

Brief Summary

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Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life.

Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations.

Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.

Detailed Description

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This prospective trial will enroll eligible adults with OAB recruited from Urology and urogynecology clinics. Subjects have a baseline evaluation with questionnaires, clinical data, and fMRI to assess brain activity during urinary urgency. All subjects receive the intervention: 5 daily sessions of rTMS to regions of interest. Electromyography will assess pelvic floor muscle activity at rest during rTMS. Following the intervention, an evaluation with questionnaires, clinical data, and fMRI is repeated.

Conditions

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Overactive Bladder Overactive Bladder Syndrome Urge Incontinence Urgency-frequency Syndrome Urinary Incontinence Urinary Incontinence, Urge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study, all subjects receive the same intervention
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Transcranial magnetic stimulation

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Magstim Rapid2 Therapy System

Interventions

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Transcranial Magnetic Stimulation

Magstim Rapid2 Therapy System

Intervention Type DEVICE

Other Intervention Names

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Magstim Rapid2 Therapy System

Eligibility Criteria

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Inclusion Criteria

* Females \& Males
* 40 to 80 years old
* 3 months of OAB symptoms without active urinary tract infection currently
* 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
* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Almarez, BBA

Role: STUDY_DIRECTOR

Houston Methodist Obstetrics & Gynecology Department

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Almarez, BBA

Role: CONTACT

713-441-5920

Facility Contacts

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Michelle Almarez, BBA

Role: primary

713-441-5920

Other Identifiers

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PRO00037607

Identifier Type: -

Identifier Source: org_study_id

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