Overactive BladderTMS_OABNCT06198439
rTMS in Overactive Bladder
A study testing Transcranial Magnetic Stimulation in people with Overactive Bladder and Overactive Bladder Syndrome, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder
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.
Read the 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.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urgency-frequency Syndrome, Urinary Incontinence, Urinary Incontinence, Urge
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called Magstim Rapid2 Therapy System
Magstim Rapid2 Therapy System
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | All study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation) Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional brain activity
Activity in the supplemental motor area and prefrontal cortex during full bladder
Measured: Post-intervention at: 0 to 3 days
Functional connectivity
Connectivity of regions of interest with a full bladder and empty bladder state
Measured: Post-intervention at: 0 to 3 days
Secondary outcomes (5)
Pelvic floor muscle activity
Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest
Measured: on day 5 of the intervention
Urinary frequency
Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Measured: Post-intervention at: 1 day, 3 weeks, 6 weeks
Urgency episodes
Mean urgency episodes per 24 hours (n) 2- day bladder diary (higher score is worse outcome)
Measured: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB Symptom Bother
OAB-q symptom burden score (higher score is worse outcome)
Measured: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB related Quality of life
OAB-q health-related quality of life score (higher score is a better outcome)
Measured: Post-intervention at: 1 day, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion9 Dec 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study, all subjects receive the same intervention
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Almarez, BBA, Study director, Houston Methodist Obstetrics & Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198439
- Sponsor's protocol ID
- PRO00037607
- Acronym
- TMS_OAB
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Salazar BH, Colbert K, Hoffman KA, Khavari R, High RA. Protocol for a prospective, single-arm pilot trial assessing the clinical and supraspinal neural effects of non-invasive transcranial neuromodulation in adults with overactive bladder. Contemp Clin Trials Commun. 2026 Sep 11;54:101680. doi: 10.1016/j.conctc.2026.101680. eCollection 2026 Dec.
PubMed 42781031
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Neural and Clinical Effects of Non-Invasive Transcranial Neuromodulation in Adults With Overactive Bladder
- ClinicalTrials.gov ID
- NCT06198439
- Acronym / sponsor ID
- TMS_OAB / PRO00037607
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urgency-frequency Syndrome, Urinary Incontinence, Urinary Incontinence, Urge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study, all subjects receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | Device: Transcranial Magnetic StimulationAll study subjects undergo five sessions of rTMS. The 40-minute sessions target the supplemental motor area (inhibitory stimulation) and prefrontal cortex (excitatory stimulation) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females \& Males
- 40 to 80 years old
- 3 months of OAB symptoms without active urinary tract infection currently
- Bladder diary:
- Montreal Cognitive Assessment (MoCA) score >10
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Magstim Rapid2 Therapy SystemMagstim Rapid2 Therapy System | Device | Transcranial magnetic stimulation |
Primary outcome
Regional brain activity
Time frame: Post-intervention at: 0 to 3 days
Activity in the supplemental motor area and prefrontal cortex during full bladder
Functional connectivity
Time frame: Post-intervention at: 0 to 3 days
Connectivity of regions of interest with a full bladder and empty bladder state
5 secondary outcomes
Pelvic floor muscle activity
Time frame: on day 5 of the intervention
Urinary frequency
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Urgency episodes
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB Symptom Bother
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
OAB related Quality of life
Time frame: Post-intervention at: 1 day, 3 weeks, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42781031Salazar BH, Colbert K, Hoffman KA, Khavari R, High RA. Protocol for a prospective, single-arm pilot trial assessing the clinical and supraspinal neural effects of non-invasive transcranial neuromodulation in adults with overactive bladder. Contemp Clin Trials Commun. 2026 Sep 11;54:101680. doi: 10.1016/j.conctc.2026.101680. eCollection 2026 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Almarez, BBA study director
Houston Methodist Obstetrics & Gynecology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Overactive Bladder and Overactive Bladder Syndrome, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional brain activity (time frame: Post-intervention at: 0 to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.