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NCT Number: NCT04193709

Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

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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Key information

Conditions

Urinary Bladder, Neurogenic Autonomic Dysreflexia Autonomic Nervous System Diseases Blood Pressure Bowel Incontinence Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 19.1194 Will determine change in systolic blood pressure during filling during cystometry

    Time frame: 2 hours

    We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments

  2. 19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments

    Time frame: 1 hour

    We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments

  3. 17.1024 BB-IS-2 Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)

    Time frame: 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 outcomes

  1. 19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments

    Time frame: 3 hours

    Will record participant's verbalized sensations while also measuring blood pressure during Urodynamics cystometry and Anorectal Manometry assessments

  2. 19.1194 Will determine if level of injury, completeness of injury or gender have a significant effect on maximum changes in blood pressure

    Time frame: 5 years

    Will use multi-variable statistical analysis to determine significance

  3. 17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months)

    Time frame: 6 months

    Using urodynamics we will measure bladder capacity in mLTime Frame: Baseline, 80 sessions (6 months)

  4. 17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months)

    Time frame: 6 months

    Using urodynamics we will measure detrusor pressure in cmH2O.Time Frame: Baseline, 80 sessions (6 months)

  5. 17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months)

    Time frame: 6 months

    Using anorectal manometry will will measure mean resting anal pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months)

  6. 17.1024 BB-IS-2 Change from baseline in mean squeeze pressure after 80 sessions (6 months)

    Time frame: 6 months

    Using anorectal manometry we will measure mean squeeze pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months)

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2019
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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