Clinical trial NCT03036527: Recovery of Bladder and Sexual Function After Spinal Cord Injury
Official title: Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Bladder
Sexual Function
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.

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

Primary outcomes:
measure: Bladder Storage
timeFrame: 5 years, 2 months
measure: Bladder Emptying
timeFrame: 5 years, 2 months
measure: Bladder Pressure
timeFrame: 5 years, 2 months
measure: Compliance
timeFrame: 5 years, 2 months
Secondary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: 5 years, 2 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: National Institutes of Health (NIH)
name: Ralph Nitkin, PhD
role: STUDY_DIRECTOR
References:
citation: Hubscher CH, Wyles J, Gallahar A, Johnson K, Willhite A, Harkema SJ, Herrity AN. Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Arch Phys Med Rehabil. 2021 May;102(5):865-873. doi: 10.1016/j.apmr.2020.11.002. Epub 2020 Dec 3.
citation: Hubscher CH, Herrity AN, Williams CS, Montgomery LR, Willhite AM, Angeli CA, Harkema SJ. Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One. 2018 Jan 31;13(1):e0190998. doi: 10.1371/journal.pone.0190998. eCollection 2018.