Recovery of Bladder and Sexual Function After Spinal Cord Injury

Not Applicable

Completed

Conditions: Spinal Cord Injuries

Interventions: Procedure: Activity-based locomotor training
Procedure: Activity-based upper arm ergometry
Procedure: Activity-based stand training
Procedure: Activity-based training + spinal epidural stimulation

Registration Number: NCT03036527

Lead Sponsor: University of Louisville

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity-based locomotor training	Activity-based locomotor training	To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.
Activity-based upper arm ergometry	Activity-based upper arm ergometry	To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.
Activity based training + spinal epidural stimulation	Activity-based locomotor training	combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
Activity based training + spinal epidural stimulation	Activity-based training + spinal epidural stimulation	combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
Activity based training + spinal epidural stimulation	Activity-based stand training	combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
Activity-based stand training	Activity-based stand training	To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.

Primary Outcome Measures

Name	Time	Method
Bladder Storage	5 years, 2 months	Bladder capacity (mlH2O)
Compliance	5 years, 2 months	Bladder Compliance (ml/cmH2O)
Bladder Emptying	5 years, 2 months	Voiding Efficiency (% voided)
Bladder Pressure	5 years, 2 months	Leak point pressure (cmH2O)

Secondary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF)	5 years, 2 months	There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Scoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes. Overall IIEF score range is 5-75; total \>61.8 considered normal.