Deep Brain Stimulation in Patients With LUTS

Neurogenic Bladder Clinical Trial

Official title:

The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202251
• Other study ID #: Pro00016473
• Status: Completed
• Start date: April 11, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: September 2021
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Dysfunction
• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Other:
• It's is a cohort
It is a prospective, observational, cohort study

Locations

Country	Name	City	State
United States	Houston Methodist Research Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in AUASS (American Urological Association Symptom Score)	Subjective assessment of Deep Brain Stimulation (DBS) effect on urinary symptoms measured by AUASS questionnaire (from none= 0 to most severe=35)	Change in AUA symptoms score at Post DBS Implant (= 60 days after procedure) measurement compared to Pre-DBS (=60 day prior to procedure) measurement.
Primary	Change from Baseline in I-QOL (Incontinence Quality of Life score)	Subjective assessment of DBS effect on urinary incontinence related QOL measured by I-QOL questionnaire. Scores would be from 0 to 100. Higher scores indicate less impact of urinary incontinence on quality of life	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	Change from Baseline in Neurogenic Detrusor Overactivity (NDO)	Using Urodynamic Study (UDS) to objectively assess DBS effect on Neurogenic Detrusor Overactivity (NDO) (Changed status from Yes to No- Yes means we see NDO at time of UDS , No means we do not see NDO at the time of UDS and we check to see if this status changes from Yes in Pre-DBS study to No in Post DBS and year 2 follow-up study ) and Bladder Compliance which is measured by diving bladder volume change to bladder pressure change (ml/cmH2O) during bladder filling at the time of UDS.	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.
Secondary	Change from baseline in Bladder Compliance	Bladder Compliance is measured by dividing bladder volume change to bladder pressure change (ml/cmH2O) during bladder filling at the time of UDS. Bladder Compliance= ( Bladder Volume at the end of bladder filling- Bladder Volume at the beginning of bladder filling)/ Bladder Pressure at the end of bladder filling- Bladder Pressure at the beginning of bladder filling)	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.