Improving bladder and sexual function after spinal cord injury
Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
This study tests whether spinal cord epidural stimulation can help people with spinal cord injuries improve their bladder and sexual function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT04193709 on ClinicalTrials.gov |
What this trial studies
This study investigates the recovery of bladder and sexual function in individuals with spinal cord injuries by examining the effects of spinal cord epidural stimulation. It aims to monitor autonomic dysreflexia and its relationship with bladder and bowel function through controlled laboratory settings and mobile at-home monitoring. Additionally, the study will analyze urinary biomarkers to identify underlying mechanisms and regulate cardiovascular function as part of bladder and bowel management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with neurogenic bladder and bowel dysfunction due to spinal cord injuries classified as AIS A to D.
Not a fit: Patients with prior Botox injections for bladder treatment, colostomy bags, or those who are ventilator-dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance bladder and sexual function in patients with spinal cord injuries, improving their quality of life.
How similar studies have performed: Other studies utilizing spinal cord stimulation have shown promise in improving bladder function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Charles Hubscher, PhD — University of Louisville
- Study coordinator: Charles Hubscher, PhD
- Email: charles.hubscher@louisville.edu
- Phone: 502-852-3058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.