- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03202251
Deep Brain Stimulation in Patients With LUTS
3 september 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
6
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
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Houston, Texas, Förenta staterna, 77030
- Houston Methodist Research Institute
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in AUASS (American Urological Association Symptom Score)
Tidsram: 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)
|
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)
Tidsram: 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
|
Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in Neurogenic Detrusor Overactivity (NDO)
Tidsram: 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.
|
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
Tidsram: 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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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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 april 2017
Primärt slutförande (Faktisk)
25 mars 2020
Avslutad studie (Faktisk)
25 mars 2020
Studieregistreringsdatum
Först inskickad
28 april 2017
Först inskickad som uppfyllde QC-kriterierna
26 juni 2017
Första postat (Faktisk)
28 juni 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00016473
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
To be determined
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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