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Recruiting NCT02331979

Improving Bladder Function in SCI by Neuromodulation

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electromagnetic Neuromodulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injury. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.

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.

Interventions

  • Device Electromagnetic Neuromodulation
    Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.

Primary outcome measures

  • Urine flow and volume [Time frame: Months 1-48]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Identifiers

NCT: NCT02331979 · 14-000932

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗