Recovery of Bladder and Sexual Function After Spinal Cord Injury

University of Louisville (UOFL)

Status: Completed

Conditions: Spinal Cord Injuries

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03036527

5R01HD080205 (U.S. NIH Grant/Contract)

14.0062 Bladder Sex Fxn

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Activity-based locomotor training

Experimental group

Description:

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.

Treatment:

Procedure: Activity-based locomotor training

Activity-based stand training

Experimental group

Description:

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.

Treatment:

Procedure: Activity-based stand training

Activity-based upper arm ergometry

Experimental group

Description:

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.

Treatment:

Procedure: Activity-based upper arm ergometry

Activity based training + spinal epidural stimulation

Experimental group

Description:

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Treatment:

Procedure: Activity-based locomotor training

Procedure: Activity-based training + spinal epidural stimulation

Procedure: Activity-based stand training