Recovery of Bladder and Sexual Function After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036527
• Other study ID #: 14.0062 Bladder Sex Fxn
• Secondary ID: 5R01HD080205
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2019

Study information

• Verified date: June 2024
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Procedure:
• Activity-based locomotor training
The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).
• Activity-based stand training
The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.
• Activity-based upper arm ergometry
The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.
• Activity-based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Storage	Bladder capacity (mlH2O)	5 years, 2 months
Primary	Bladder Emptying	Voiding Efficiency (% voided)	5 years, 2 months
Primary	Bladder Pressure	Leak point pressure (cmH2O)	5 years, 2 months
Primary	Compliance	Bladder Compliance (ml/cmH2O)	5 years, 2 months
Secondary	International Index of Erectile Function (IIEF)	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.	5 years, 2 months