Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia, Bowel Incontinence
Conditions
Brief summary
This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.
Interventions
For arm 2, optimal stimulation parameters (cathode/anode configuration, stimulation frequency and voltage; placement of electrode from L1 to S1) will be identified for blood pressure and bladder pressure to achieve a bladder capacity in the target normative range of 400-450 mLs. Spinal cord epidural stimulation will then be used in a controlled lab setting for the regulation of blood pressure and heart rate to maintain normative values (target systolic pressure of 110-120 mmHg) and bladder pressure below 10 cmH2O during bladder filling up to the targeted capacity (fill volume of 400 mLs).
Sponsors
University of Louisville
National Institutes of Health (NIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Arm 1 Inclusion Criteria: * At least 18 years of age; * AIS A to D; * Neurogenic bladder and bowel dysfunction; * Stable medical condition Arm 2 Inclusion Criteria: * At least 18 years of age; * AIS A to D; * Neurogenic bladder and bowel dysfunction; * Use of intermittent catheterization for bladder emptying; * Prior implantation of a Medtronic scES array Arms 1 and 2
Exclusion criteria
* Prior Botox injections of the bladder and/or bladder augmentation surgery; * Colostomy bag, * Ventilator dependent; * Any implanted pump (i.e. Baclofen pump, pain pump, etc.); * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 19.1194 Will determine change in systolic blood pressure during filling during cystometry | 2 hours | We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments |
| 19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments | 1 hour | We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments |
| 17.1024 BB-IS-2 Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months) | 6 months | We will record systolic blood pressure every five minutes over a 24 hour period using a 24-hour blood pressure monitorTime Frame: Baseline, 80 sessions (6 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments | 3 hours | Will record participant's verbalized sensations while also measuring blood pressure during Urodynamics cystometry and Anorectal Manometry assessments |
| 19.1194 Will determine if level of injury, completeness of injury or gender have a significant effect on maximum changes in blood pressure | 5 years | Will use multi-variable statistical analysis to determine significance |
| 17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months) | 6 months | Using urodynamics we will measure bladder capacity in mLTime Frame: Baseline, 80 sessions (6 months) |
| 17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months) | 6 months | Using urodynamics we will measure detrusor pressure in cmH2O.Time Frame: Baseline, 80 sessions (6 months) |
| 17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months) | 6 months | Using anorectal manometry will will measure mean resting anal pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months) |
| 17.1024 BB-IS-2 Change from baseline in mean squeeze pressure after 80 sessions (6 months) | 6 months | Using anorectal manometry we will measure mean squeeze pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles Hubscher, PhD
University of Louisville
Outcome results
None listed