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| ID | Type | Description | Link |
|---|---|---|---|
| OT2OD024898 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measure symptomatic indices of autonomic dysreflexia | No Intervention | The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation. | |
| Cardiovascular spinal cord epidural stimulation | Experimental | The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Epidural Stimulation | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 19.1194 Will determine change in systolic blood pressure during filling during cystometry | We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments | 2 hours |
| 19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments | We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments | 1 hour |
| 17.1024 BB-IS-2 Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments | Will record participant's verbalized sensations while also measuring blood pressure during Urodynamics cystometry and Anorectal Manometry assessments | 3 hours |
| 19.1194 Will determine if level of injury, completeness of injury or gender have a significant effect on maximum changes in blood pressure |
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Arm 1 Inclusion Criteria:
Arm 2 Inclusion Criteria:
Arms 1 and 2 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Hubscher, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D020211 | Autonomic Dysreflexia |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).
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Will use multi-variable statistical analysis to determine significance |
| 5 years |
| 17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months) | Using urodynamics we will measure bladder capacity in mLTime Frame: Baseline, 80 sessions (6 months) | 6 months |
| 17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months) | Using urodynamics we will measure detrusor pressure in cmH2O.Time Frame: Baseline, 80 sessions (6 months) | 6 months |
| 17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months) | Using anorectal manometry will will measure mean resting anal pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months) | 6 months |
| 17.1024 BB-IS-2 Change from baseline in mean squeeze pressure after 80 sessions (6 months) | Using anorectal manometry we will measure mean squeeze pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months) | 6 months |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D020196 | Trauma, Nervous System |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |