Deep Brain Stimulation in Patients With LUTS
2021년 9월 3일 업데이트: Rose Khavari, M.D., The Methodist Hospital Research Institute
The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
6
연락처 및 위치
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연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Houston Methodist Research Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in AUASS (American Urological Association Symptom Score)
기간: Change in AUA symptoms score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
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Subjective assessment of Deep Brain Stimulation (DBS) effect on urinary symptoms measured by AUASS questionnaire (from none= 0 to most severe=35)
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Change in AUA symptoms score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
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Change from Baseline in I-QOL (Incontinence Quality of Life score)
기간: Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
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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
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Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Neurogenic Detrusor Overactivity (NDO)
기간: 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.
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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.
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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.
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Change from baseline in Bladder Compliance
기간: 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.
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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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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.
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2017년 4월 11일
기본 완료 (실제)
2020년 3월 25일
연구 완료 (실제)
2020년 3월 25일
연구 등록 날짜
최초 제출
2017년 4월 28일
QC 기준을 충족하는 최초 제출
2017년 6월 26일
처음 게시됨 (실제)
2017년 6월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 3일
마지막으로 확인됨
2021년 9월 1일
추가 정보
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