Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT06072703
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06072703
Study Brief:
Protocol Section:
NCT06072703