Deep Brain Stimulation in Patients With LUTS

NCT03202251 | Completed

• 1 other identifier: Pro00016473
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Dysfunction; Neurogenic Bladder

Keywords

overactive bladder; underactive bladder; urinary incontinence

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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)

  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

  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.

Interventions

It's is a cohort OTHER

It is a prospective, observational, cohort study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Bladder, Underactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders

Study Officials

• Rose Khavari, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Center for Restorative Pelvic Medicine

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: June 28, 2017
• Study Start: April 11, 2017
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)