RECRUITING

rTMS in Overactive Bladder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder

Quick Facts

Study Start:2024-01-08
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06198439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females \& Males
  2. * 40 to 80 years old
  3. * 3 months of OAB symptoms without active urinary tract infection currently
  4. * Bladder diary:
  5. * Mean voids/24 hours ≥ 8.0
  6. * Mean urgency episodes/24 hours ≥ 3.0
  7. * Montreal Cognitive Assessment (MoCA) score \>10
  1. * Pregnant, nursing, or self-report of planning to become pregnant.
  2. * Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual
  3. * Qmax \< 10 ml/s in males on uroflow
  4. * \< 20th percentile on Liverpool nomogram
  5. * Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter
  6. * Personal or immediate family history of seizure disorder
  7. * Taking (bupropion) Wellbutrin or heavy alcohol use
  8. * Parkinson's disease, Multiple sclerosis, spinal cord injury
  9. * Intracranial lesions and hemorrhagic stroke within the last 12 months
  10. * History of interstitial cystitis, pelvic radiation, bladder augmentation
  11. * Intradetrusor botulinum toxin injections within 6 months
  12. * Pelvic floor therapy within 2 months.
  13. * Active/on-mode Sacral nerve stimulator (eligible if turned off)
  14. * Incarcerated patients

Contacts and Locations

Study Contact

Michelle Almarez, BBA
CONTACT
713-441-5920
almarez@houstonmethodist.org

Principal Investigator

Michelle Almarez, BBA
STUDY_DIRECTOR
Houston Methodist Obstetrics & Gynecology Department

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Michelle Almarez, BBA, STUDY_DIRECTOR, Houston Methodist Obstetrics & Gynecology Department

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

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