NCT03202251|Completed
Deep Brain Stimulation in Patients With LUTS
The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
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The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
Sponsor study identifier
observational
6
1 country
1
Study Start
April 11, 2017
Actual (reported)Primary Completion
March 25, 2020
Actual (reported)Study Completion
March 25, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2017
Actual (reported)April 28, 2017
Actual (reported)June 28, 2017
Actual (reported)March 25, 2020
Actual (reported)March 25, 2020
Actual (reported)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.
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.
Change from Baseline in Neurogenic Detrusor Overactivity (NDO)
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.
Change from baseline in Bladder Compliance
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.
It is a prospective, observational, cohort study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Rose Khavari, MD
The Methodist Hospital Research Institute
6 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2017
First Posted
June 28, 2017
Study Start
April 11, 2017
Actual (reported)Feasibility of Using Contrast Enhanced Voiding Urosonography (CeVUS) During Urodynamic Studies
Contact the study team to confirm eligibility.
Primary Completion
March 25, 2020
Actual (reported)Study Completion
March 25, 2020
Actual (reported)Last Updated
September 5, 2021
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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