Brain Targets in Patients With Bladder Emptying Difficulties

Conditions:Other Indications, Parkinsons Disease, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Age Range:18 - 80
Start Date:July 1, 2018
End Date:July 31, 2021
Contact:Rashmi Pande, BDS,MS,CCRP

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Supraspinal Mechanisms Involved in Voiding Dysfunction.

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.

Difficulty in bladder emptying (Voiding dysfunction,VD) is a costly urinary condition that
leads to urinary tract infections/stones, sepsis, bladder loss, and permanent kidney damage.
VD can be present in patients with or without neurologic/brain disorders. Currently the only
available therapies for VD include bladder catheters or intermittent self-catheterization.
Catheterization is a burden especially in patients with nerve damage, hand skills may be
limited. The cost and morbid side effects of catheterizations in patients (blood in the
urine, pain, trauma, strictures, and infections) requires investigators to develop new
therapies that are beyond the bladder. Such new therapies could target the brain (where
bladder control is located).

In this proposal, investigators plan to further characterize the brain regions involved in
bladder emptying for each patient and ,perform brain modulation, targeting these regions as a
possible therapy for VD.

Patients with bladder dysfunction will be divided into two groups: Group 1: patients with VD;
and Group 2: patients without VD. Specific Aim 1: To evaluate brain pattern in both groups
and compare them to each other at the time of bladder emptying. Specific Aim 2: To evaluate
reliability of the nerve fibers in the brain and see whether damage to these fibers is
related to difficulty emptying the bladder. Specific Aim 3: To perform non-invasive brain
stimulation on specific regions of the brain responsible for bladder control to improve
bladder emptying.

This study is an interventional Study: The investigators have completed a well-powered study
on twenty-seven female MS patients during their bladder storage phase. Aims 1 and 2 use the
data from previously completed trial and investigators will perform additional imaging
analysis on it. Aim 3 is a new and small trial in which investigators planned to modulate the
regions of the brain that are related to bladder control.

Approximately 16 study participants will be enrolled at Houston Methodist, and 16 throughout
the study.

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
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
We found this trial at
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Rose Khavari, MD
Phone: 713-363-9154
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
Houston, TX
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