- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331979
Improving Bladder Function in SCI by Neuromodulation
February 10, 2026 updated by: Daniel Lu, MD, PhD, University of California, Los Angeles
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.
Neuromodulation will be in the form of transcutaneous electrical stimulation and/or magnetic stimulation.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel Lu, MD PhD
- Phone Number: 310-825-4321
- Email: dclu@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Daniel C Lu, MD PhD
- Phone Number: 310-267-2975
- Email: dclu@mednet.ucla.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male 18-45 years;
- At least 1 year post-injury;
- Non-progressive SCI at C2-T8 (non-conus injury);
- Motor Complete ASIA (A or B);
- Neurogenic bladder requiring clean intermittent straight catheterization;
- Able to attend twice weekly testing sessions for 6 months.
- Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.
Exclusion Criteria:
- History of autonomic dysreflexia;
- Ventilator dependency;
- Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection;
- Clinically significant depression or ongoing drug abuse;
- Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.); 6. Prostatic hypertrophy or bladder outlet disorder;
7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stimulation of Non-Naive
Evaluate neuromodulation in 6 subjects with prior motor training.
|
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
|
|
Experimental: Stimulation of Naive
Evaluate neuromodulation in 6 naive subjects.
|
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
|
|
Experimental: Stimulation
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
|
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Urine flow and volume
Time Frame: Months 1-48
|
Months 1-48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
January 3, 2015
First Submitted That Met QC Criteria
January 3, 2015
First Posted (Estimated)
January 6, 2015
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Spinal Cord Injuries
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Analgesia
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- 14-000932
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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