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Deep Brain Stimulation in Patients With LUTS

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ClinicalTrials.gov Identifier: NCT03202251
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rose Khavari, M.D., The Methodist Hospital System

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.

Condition or disease Intervention/treatment
Bladder Dysfunction Neurogenic Bladder Other: It's is a cohort

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.

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : April 10, 2020
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Change from Baseline in AUASS (American Urological Association Symptom Score) [ Time Frame: Change in AUA symptoms score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement. ]
    Subjective assessment of Deep Brain Stimulation (DBS) effect on urinary symptoms measured by AUASS questionnaire (from none= 0 to most severe=35)

  2. Change from Baseline in I-QOL (Incontinence Quality of Life score) [ Time Frame: Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement. ]
    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


Secondary Outcome Measures :
  1. Change from Baseline in Neurogenic Detrusor Overactivity (NDO) [ Time Frame: 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. ]
    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.

  2. Change from baseline in Bladder Compliance [ Time Frame: 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. ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202251


Contacts
Contact: Rashmi Pande, BDS,MS,CCRP 713-363-9154 rpande@houstonmethodist.org
Contact: Rose Khavari, MD 713-441-6455 rkhavari@houstonmethodist.org

Locations
United States, Texas
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Rose Khavari, MD    713-441-6455    rkhavari@houstonmethodist.org   
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Rose Khavari, MD The Methodist Hospital System

Responsible Party: Rose Khavari, M.D., Director of Research, Center for Restorative Pelvic Medicine, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03202251     History of Changes
Other Study ID Numbers: Pro00016473
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rose Khavari, M.D., The Methodist Hospital System:
overactive bladder
underactive bladder
urinary incontinence

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urinary Bladder, Neurogenic
Urological Manifestations
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases