Skip to main content
OpenTrials
Completed

NCT Number: NCT03036527

Recovery of Bladder and Sexual Function After Spinal Cord Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity-based locomotor training

Procedure

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).

Other names: Locomotor training

Activity-based stand training

Procedure

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.

Other names: Stand training

Activity-based upper arm ergometry

Procedure

The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.

Other names: Arm Crank

Activity-based training + spinal epidural stimulation

Procedure

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

Primary outcomes

  1. Bladder Storage

    Time frame: 5 years, 2 months

    Bladder capacity (mlH2O)

  2. Bladder Emptying

    Time frame: 5 years, 2 months

    Voiding Efficiency (% voided)

  3. Bladder Pressure

    Time frame: 5 years, 2 months

    Leak point pressure (cmH2O)

  4. Compliance

    Time frame: 5 years, 2 months

    Bladder Compliance (ml/cmH2O)

Secondary outcomes

  1. International Index of Erectile Function (IIEF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.