Status:
RECRUITING
Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Neurogenic Bladder
Multiple Sclerosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Neurogenic overactive bladder (NOAB), characterized by urinary frequency, urgency or urgency incontinence symptoms occurring during the storage phase of the bladder, is the most common urinary complai...
Detailed Description
Neurogenic overactive bladder (NOAB), characterized by urinary frequency, urgency or urgency incontinence symptoms occurring during the storage phase of the bladder, is the most common urinary complai...
Eligibility Criteria
Inclusion
- Adult women (≥ 18 years of age)
- Clinically stable MS defined as ExpandedDisability Status Score (EDSS) ≤ 7.5without exacerbation worsening in the preceding 6 months prior to study entry
- Neurogenic Lower Urinary Tract Dysfunction symptoms ≥ 3 months with NBSS total ≥ 15
- Individuals with Montreal Cognitive Assessment (MoCA) score \>10 will be eligible
- At least one bladder storage symptoms (e.g., urinary frequency, urinary urgency, nocturia with or without incontinence) indicated by OAB -AT≥ 8
- Individuals with active urinary tract infection (UTI) will be treated and will be enrolled after negative urinalysis
Exclusion
- Pregnant/planning to become pregnant or nursing
- Urodynamic findings of bladder outlet obstruction
- Baclofen or other intrathecal pumps, Pacemakers.
- History of seizure disorder (SZ), immediate family of SZ disorder, in addition to individuals who are taking any medications such as (bupropion) Wellbutrin or substances (ex: heavy alcohol use) that would lower seizure threshold will be excluded.
- History of bipolar disorder, or individuals who are taking medications that can exacerbate the condition such as tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-nor-epinephrine reuptake inhibitors, anti-psychotics, lithium, bupropion (Wellbutrin) and antihistamines will be excluded.
- All intracranial lesions and hemorrhagic stroke will be excluded
- History of moderate to severe heart disease or unstable angina
- History of Autonomic Dysreflexia
- History of interstitial cystitis, pelvic radiation
- Intra-detrusor botulinumtoxinA (BTX-A) injection over the past 6 months
- Incarcerated patients will be excluded.
- Active sacral nerve stimulation (SNS) device or any other spinal stimulators
- Indwelling urethral or suprapubic catheter
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06072703
Start Date
October 30 2023
End Date
December 31 2027
Last Update
February 14 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030