Deep Brain Stimulation in Patients With LUTS

NCT ID: NCT03202251

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2020-03-25

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

It's is a cohort

It is a prospective, observational, cohort study

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rose Khavari, M.D.

Director of Research, Center for Restorative Pelvic Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rose Khavari, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Research Institute

Houston, Texas, United States

Countries

United States

Other Identifiers

Pro00016473

Identifier Type: -

Identifier Source: org_study_id