Recovery of Bladder and Sexual Function After Spinal Cord Injury

June 12, 2024 updated by: Susan Harkema PhD, University of Louisville

Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
Other Names:
  • Locomotor training
Experimental: 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.
Procedure: 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.
Other Names:
  • Stand training
Experimental: 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.
Procedure: 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.
Other Names:
  • Arm Crank
Experimental: Activity based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
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).
Other Names:
  • Locomotor training
Procedure: 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.
Other Names:
  • Stand training
Procedure: Activity-based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder Storage
Time Frame: 5 years, 2 months
Bladder capacity (mlH2O)
5 years, 2 months
Bladder Emptying
Time Frame: 5 years, 2 months
Voiding Efficiency (% voided)
5 years, 2 months
Bladder Pressure
Time Frame: 5 years, 2 months
Leak point pressure (cmH2O)
5 years, 2 months
Compliance
Time Frame: 5 years, 2 months
Bladder Compliance (ml/cmH2O)
5 years, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

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

Investigators

  • Study Director: Ralph Nitkin, PhD, National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimated)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.0062 Bladder Sex Fxn
  • 5R01HD080205 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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