Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

• Status: Not yet recruiting
• Trial end date: 2028-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: United States Department of Defense
• Treatments: Probenecid

Criteria

Inclusion Criteria:

1. Subject has a traumatic spinal cord injury.

2. Subject is male and is 18 years or older.

Exclusion Criteria:

1. Subject has been injured less than 1 year.

2. The subject is known to be azoospermic.

3. The subject has an indwelling urethral Foley catheter.

4. Subject is under the age of 18 years.

5. Subject has an unstable medical condition including, but not limited to, Crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the Investigator.

6. Subject is unable to consent or comprehend the procedures and their implications.

7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.

8. Any subject for whom the procedure or medication is otherwise contraindicated.

9. Subject has hypersensitivity to probenecid.

10. Subject has a history of uric acid kidney stones and/or peptic ulcer.

11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.

12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.

13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.