<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036527</url>
  </required_header>
  <id_info>
    <org_study_id>14.0062 Bladder Sex Fxn</org_study_id>
    <nct_id>NCT03036527</nct_id>
  </id_info>
  <brief_title>Recovery of Bladder and Sexual Function After Spinal Cord Injury</brief_title>
  <official_title>Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting&#xD;
      quality of life after spinal cord injury. The insights of how activity-based training affects&#xD;
      bladder function may prove to be useful to other patient populations with bladder and sexual&#xD;
      dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate&#xD;
      investigations of training's effects within other systems such as bowel dysfunction.&#xD;
      Locomotor training could help promote functional recovery and any insights gained from these&#xD;
      studies will enhance further investigation of the effect of bladder functioning after spinal&#xD;
      cord injury. In addition, as suggested by a study of one of our initial participants, a&#xD;
      reduction in the use and/or dosage of medication to enhance sexual function is a possible&#xD;
      outcome, medications which carry risks and side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To determine the effects of weight-bearing task-specific training for locomotion&#xD;
      (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in&#xD;
      humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing&#xD;
      (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bladder Storage</measure>
    <time_frame>5 years</time_frame>
    <description>Bladder capacity (mlH2O)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bladder Emptying</measure>
    <time_frame>5 years</time_frame>
    <description>Voiding Efficiency (% voided)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bladder Pressure</measure>
    <time_frame>5 years</time_frame>
    <description>Leak point pressure (cmH2O)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>5 years</time_frame>
    <description>Bladder Compliance (ml/cmH2O)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Index of Erectile Function (IIEF), Female Sexual function index (FSFI)</measure>
    <time_frame>5 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Activity-based locomotor training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity-based stand training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity-based upper arm ergometry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Activity-based locomotor training</intervention_name>
    <description>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).</description>
    <arm_group_label>Activity-based locomotor training</arm_group_label>
    <other_name>Locomotor training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Activity-based stand training</intervention_name>
    <description>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.</description>
    <arm_group_label>Activity-based stand training</arm_group_label>
    <other_name>Stand training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Activity-based upper arm ergometry</intervention_name>
    <description>The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.</description>
    <arm_group_label>Activity-based upper arm ergometry</arm_group_label>
    <other_name>Arm Crank</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria: Inclusion Criteria:&#xD;
&#xD;
          -  stable medical condition without cardiopulmonary disease or dysautonomia that would&#xD;
             contraindicate locomotor training, stand, or non-weight bearing training&#xD;
&#xD;
          -  no painful musculoskeletal dysfunction,&#xD;
&#xD;
          -  unhealed fracture, contracture, pressure sore or urinary tract infection that might&#xD;
             interfere with training&#xD;
&#xD;
          -  no clinically significant depression or ongoing drug abuse;&#xD;
&#xD;
          -  clear indications that the period of spinal shock is concluded determined by presence&#xD;
             of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard&#xD;
             inpatient rehabilitation&#xD;
&#xD;
          -  non- progressive suprasacral spinal cord injury&#xD;
&#xD;
          -  bladder and sexual dysfunction as a result of spinal cord injury&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  unstable medical condition with cardiopulmonary disease or dysautonomia that would&#xD;
             contraindicate locomotor training, stand, or non-weight bearing training;&#xD;
&#xD;
          -  painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores&#xD;
             or urinary tract infections that might interfere with training&#xD;
&#xD;
          -  clinically significant depression or ongoing drug abuse;&#xD;
&#xD;
          -  clear indications that the period of spinal shock has not concluded and not discharged&#xD;
             from standard inpatient rehabilitation&#xD;
&#xD;
          -  progressive spinal cord injury&#xD;
&#xD;
          -  no bladder and sexual dysfunction as a result of spinal cord injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ralph Nitkin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Institutes of Health (NIH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Susan Harkema</investigator_full_name>
    <investigator_title>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</investigator_title>
  </responsible_party>
  <keyword>Bladder</keyword>
  <keyword>Sexual Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 12, 2021</submitted>
    <returned>November 9, 2021</returned>
    <submitted>March 8, 2022</submitted>
    <returned>June 7, 2022</returned>
    <submitted>November 14, 2022</submitted>
    <returned>December 9, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036527
org study id: 14.0062 Bladder Sex Fxn
nct id: NCT03036527
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Bladder Storage
time frame: 5 years
description: Bladder capacity (mlH2O)
measure: Bladder Emptying
time frame: 5 years
description: Voiding Efficiency (% voided)
measure: Bladder Pressure
time frame: 5 years
description: Leak point pressure (cmH2O)
measure: Compliance
time frame: 5 years
description: Bladder Compliance (ml/cmH2O)
measure: International Index of Erectile Function (IIEF), Female Sexual function index (FSFI)
time frame: 5 years
description: 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
arm group label: Activity-based locomotor training
arm group type: Experimental
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.
arm group label: Activity-based stand training
arm group type: Experimental
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.
arm group label: Activity-based upper arm ergometry
arm group type: Experimental
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.
intervention type: Procedure
intervention name: Activity-based locomotor training
description: 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).
arm group label: Activity-based locomotor training
other name: Locomotor training
intervention type: Procedure
intervention name: Activity-based stand training
description: 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.
arm group label: Activity-based stand training
other name: Stand training
intervention type: Procedure
intervention name: Activity-based upper arm ergometry
description: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.
arm group label: Activity-based upper arm ergometry
other name: Arm Crank
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ralph Nitkin, PhD
role: Study Director
affiliation: National Institutes of Health (NIH)
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Susan Harkema
investigator title: 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
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No
submitted: October 12, 2021
returned: November 9, 2021
submitted: March 8, 2022
returned: June 7, 2022
submitted: November 14, 2022
returned: December 9, 2022