Clinical trial NCT03202251: Deep Brain Stimulation in Patients With LUTS
Official title: The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Dysfunction
Neurogenic Bladder
Keywords: overactive bladder
underactive bladder
urinary incontinence
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.

Brief summary: Deep brain stimulation (DBS) is a neurosurgical procedure using a device that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. As part of the patient's care, the DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. Lower urinary tract symptoms are common in patients who have underlying neurological or movement disorders and control over lower urinary tract function is poorly understood. In this study investigators are evaluating the effects of DBS on lower urinary tract function.

Detailed description: Deep brain stimulation (DBS) is a neurosurgical procedure that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. After insertion of deep electrodes, electrical stimulation will be delivered to modulate specific neurons in certain areas of the brain. Despite, the known motor effects for DBS, its nonmotor effects on other organs such as the urinary tract and bladder function remains unclear. Lower urinary tract symptoms such as frequency, urgency, urinary incontinence, or incomplete bladder emptying are common in patients who have underlying neurological or movement disorders. In addition, central neural control over lower urinary tract function is still poorly understand. In this trial investigators plan to evaluate the effects of Deep Brain Stimulators (DBS) on lower urinary tract function. This trial is designed to test the hypothesis that DBS improves objective and subjective symptoms of lower urinary tract function in specific patient populations. The investigators plan to test this hypothesis by using validated patient reported outcome questionnaires and urodynamic testing (both are part of routine care for neurogenic bladder) before and after DBS implantation. In addition, this trial will shed some light in understanding higher neural control of bladder and potentially identify target areas for future intervention.

Eligibility criteria: Inclusion Criteria:

* Patients who are a candidate for Deep Brain Stimulation (DBS) as standard care for neurologic symptoms and have a moderate or greater urinary bother American Urological Association Symptom Score (AUASS≥8)

Exclusion Criteria:

* Pregnant, breastfeeding mothers and all individuals younger than 18 years of age will be excluded. Patients with history of urinary diversion or augmentation cystoplasty will also be excluded.

Primary outcomes:
measure: Change from Baseline in AUASS (American Urological Association Symptom Score)
timeFrame: Change in AUA symptoms score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
measure: Change from Baseline in I-QOL (Incontinence Quality of Life score)
timeFrame: Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
Secondary outcomes:
measure: Change from Baseline in Neurogenic Detrusor Overactivity (NDO)
timeFrame: Change in Neurogenic Detrusor Overactivity pattern at Post DBS Implant (≥ 60 days after procedure) urodynamic study compared to Pre-DBS (≤60 day prior to procedure) urodynamic study.
measure: Change from baseline in Bladder Compliance
timeFrame: Change in bladder compliance at Post DBS Implant (≥ 60 days after procedure) urodynamic study compared to Pre-DBS (≤60 day prior to procedure) urodynamic study.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Rose Khavari, MD
role: PRINCIPAL_INVESTIGATOR
References: