Bladder DysfunctionNCT03202251
Deep Brain Stimulation in Patients With LUTS
An observational study of Bladder Dysfunction and Neurogenic Bladder, run by The Methodist Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Dysfunction, Neurogenic Bladder
- What is being tested?
- It's is a cohort
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 25 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Dysfunction, Neurogenic Bladder
- Being tested
- It's is a cohort
- Keywords
- overactive bladder, underactive bladder, urinary incontinence
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Urinary Bladder, Underactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It's is a cohortOther
It is a prospective, observational, cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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 outcomes (2)
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.
Measured: 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
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start11 Apr 2017
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Khavari, M.D., The Methodist Hospital Research Institute
- Investigators
- Rose Khavari, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202251
- Sponsor's protocol ID
- Pro00016473
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study
- ClinicalTrials.gov ID
- NCT03202251
- Acronym / sponsor ID
- Pro00016473
- Conditions
- Bladder Dysfunction, Neurogenic Bladder
- Keywords
- overactive bladder, underactive bladder, urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are a candidate for therapeutic DBS because of their neurologic symptoms and have a total AUASS of ≥8.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It's is a cohortIt is a prospective, observational, cohort study | Other | – |
Primary outcome
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)
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided. To be determined
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Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Khavari, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Dysfunction and Neurogenic Bladder, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.