N/A
N=40
Recovery of Bladder and Sexual Function After Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03036527 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2024
Primary outcome: Primary: Bladder Storage — 278.5; 447.75; 580.5; 313.0 mLH2O
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Activity-based locomotor training (Procedure); Activity-based stand training (Procedure); Activity-based upper arm ergometry (Procedure); Activity-based training + spinal epidural stimulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bladder Storage |
278.5; 447.75; 580.5; 313.0 | — |
| PRIMARY Bladder Emptying |
63.9; 6.2; 12.8; 28.0 | — |
| PRIMARY Bladder Pressure |
42.7; 33.75; 45; 29.0 | — |
| PRIMARY Compliance |
15.5; 33.8; 17.0; 20.0 | — |
| SECONDARY International Index of Erectile Function (IIEF) |
20.8; 26.4; 30.0; 29.7 | — |
Summary
Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.
Eligibility Criteria
Criteria: Inclusion Criteria:
- stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training
- no painful musculoskeletal dysfunction,
- unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training
- no clinically significant depression or ongoing drug abuse;
- clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation
- non- progressive suprasacral spinal cord injury
- bladder and sexual dysfunction as a result of spinal cord injury
Exclusion criteria
- unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;
- painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training
- clinically significant depression or ongoing drug abuse;
- clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation
- progressive spinal cord injury
- no bladder and sexual dysfunction as a result of spinal cord injury
Data sourced from ClinicalTrials.gov (NCT03036527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.