ClinicalTrials.gov
ClinicalTrials.gov Menu

Recovery of Bladder and Sexual Function After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036527
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Procedure: Activity-based locomotor training Procedure: Activity-based stand training Procedure: Activity-based upper arm ergometry Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: Arm Crank


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bladder Storage [ Time Frame: 5 years ]
    Bladder capacity (mlH2O)

  2. Bladder Emptying [ Time Frame: 5 years ]
    Voiding Efficiency (% voided)

  3. Bladder Pressure [ Time Frame: 5 years ]
    Leak point pressure (cmH2O)

  4. Compliance [ Time Frame: 5 years ]
    Bladder Compliance (ml/cmH2O)


Secondary Outcome Measures :
  1. International Index of Erectile Function (IIEF), Female Sexual function index (FSFI) [ Time Frame: 5 years ]
    International Spinal Cord Injury Data Set questionnaires for bladder and sexual function (male and female) also will be incorporated to assess management and dysfunction of these systems


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036527


Contacts
Contact: Charles Hubscher, PhD 502-852-3058 charles.hubscher@louisville.edu
Contact: Susan Harkema, PhD 502-581-8675 susanharkema@kentuckyonehealth.org

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan J Harkema, PhD    502-581-7443    locomotorresearch@kentuckyonehealth.org   
Principal Investigator: Susan J Harkema, PhD         
Sponsors and Collaborators
University of Louisville
Investigators
Study Director: Ralph Nitkin, PhD National Institutes of Health (NIH)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Susan Harkema, Professor and Associate Director, Kentucky Spinal Cord Injury Research Center, University of Louisville Owsley B. Frazier Chair in Neurological Rehabilitation Research Director, Frazier Rehab Institute Director of the NeuroRecovery Network, University of Louisville
ClinicalTrials.gov Identifier: NCT03036527     History of Changes
Other Study ID Numbers: 14.0062 Bladder Sex Fxn
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Susan Harkema, University of Louisville:
Bladder
Sexual Function

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System