N/A
N=11
Brain Targets in Patients With Bladder Emptying Difficulties
Neurogenic Bladder · Multiple Sclerosis · Voiding Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03574610 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Changes in Brain Activity After Treatment Measured Using Functional MRI — 2.759234; 3.423569; 3.000987; 3.094914 BOLD fMRI T-Value — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Rotating Permanent Magnet Stimulator (TRPMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Brain Activity After Treatment Measured Using Functional MRI |
2.759234; 3.423569; 3.000987; 3.094914; 4.046153; 2.950705 | <0.05 sig |
| SECONDARY Changes in Objective Clinical Outcomes Following Treatment |
188.1; 218.80; 189.88; 193.10; 98.70; 160.70 | 0.45 |
| SECONDARY Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment |
54.04; 29.46; 42.08 | 0.004 sig |
| SECONDARY Changes in Non-instrumented Uroflow Variable Qmax Following Treatment |
22.2; 31.00; 25.50 | 0.19 |
| SECONDARY Changes in Liverpool Nomogram Following Treatment |
34.00; 62.80; 49.63 | 0.13 |
| SECONDARY Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire |
3.10; 2.70; 1.88; 2.50; 2.20; 1.50 | 0.40 |
| SECONDARY Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire |
4.30; 2.90; 3.00; 2.60; 2.30; 1.88 | 0.044 sig |
| SECONDARY Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire |
11.70; 9.00; 9.88; 15.00; 14.10; 11.88 | 0.010 sig |
Summary
The goal of this study is to identify brain centers specifically associated with "initiation of voiding" in patients with neurogenic bladder dysfunction. Currently there is no study that has evaluated brain centers involved in initiation of voiding in patients with neurogenic voiding dysfunction.
Patients with neurogenic bladder secondary to etiologies such as Multiple Sclerosis, Parkinson's disease, and Cerebrovascular accidents will be recruited in this study. Patients will be categorized into 2 groups, those who have trouble emptying their bladder and those who urinate appropriately. Our existing and unique functional magnetic resonance imaging (fMRI)/ urodynamics (UDS) platform is an ideal platform to identify brain regions involved in bladder emptying disorders as seen in patients with neurogenic bladder dysfunction and will be used for this study. After characterizing brain regions involved in bladder emptying, the investigator propose to use noninvasive transcutaneous magnetic stimulation in a subset of patients with voiding dysfunction in aim 3.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria for subjects with neurogenic bladder:
- Patients with clinical diagnosis of neurogenic bladder
- History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, Stroke, spina bifida, Parkinson's, major spine surgery)
- 18 years or older
Specifics for MS patients:
Adult female patients with clinically stable MS [Expanded Disability Status Score (EDSS) ≤6.5], with bladder symptoms ≥3 months, will be screened. Patients will be considered to have VD if they have an increased Postvoid Residual (≥ 20% Maximum Cystometric Capacity). Patients who perform self-catheterization will be included in the VD category as well.
Exclusion Criteria
Exclusion Criteria for subjects with neurogenic bladder:
- Men (for aims 1 and 2 only), anatomical bladder outlet obstruction (anti-incontinence procedures, urethral strictures, or advanced pelvic organ prolapse). Severe debilitating MS, history of seizures, pregnancy or planning to become pregnant, contraindications to MRI, history of augmentation cystoplasty. Patients with active urinary tract infection (UTI) can be treated and subsequently screened for the trial.
- Positive urine pregnancy test at enrollment (There are no known risks to a subject's fetus. There is no known teratogenic risk associated with urodynamics or fMRI) - Cognitively impaired patients
Data sourced from ClinicalTrials.gov (NCT03574610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.