Clinical trial NCT06198439: rTMS in Overactive Bladder
Official title: Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Urge Incontinence
Urgency-frequency Syndrome
Urinary Incontinence
Urinary Incontinence, Urge
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study, all subjects receive the same intervention
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Regional brain activity
timeFrame: Post-intervention at: 0 to 3 days
measure: Functional connectivity
timeFrame: Post-intervention at: 0 to 3 days
Secondary outcomes:
measure: Pelvic floor muscle activity
timeFrame: on day 5 of the intervention
measure: Urinary frequency
timeFrame: Post-intervention at: 1 day, 3 weeks, 6 weeks
measure: Urgency episodes
timeFrame: Post-intervention at: 1 day, 3 weeks, 6 weeks
measure: OAB Symptom Bother
timeFrame: Post-intervention at: 1 day, 3 weeks, 6 weeks
measure: OAB related Quality of life
timeFrame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: Houston Methodist Obstetrics & Gynecology Department
name: Michelle Almarez, BBA
role: STUDY_DIRECTOR
References: