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Recovery of Bladder and Sexual Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity-based locomotor training
Activity-based stand training
Activity-based upper arm ergometry
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Bladder, Sexual Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Activity-based locomotor training

Activity-based stand training

Activity-based upper arm ergometry

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Bladder Storage
Bladder capacity (mlH2O)
Bladder Emptying
Voiding Efficiency (% voided)
Bladder Pressure
Leak point pressure (cmH2O)
Compliance
Bladder Compliance (ml/cmH2O)

Secondary Outcome Measures

International Index of Erectile Function (IIEF), Female Sexual function index (FSFI)
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

Full Information

First Posted
January 9, 2017
Last Updated
February 11, 2020
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03036527
Brief Title
Recovery of Bladder and Sexual Function After Spinal Cord Injury
Official Title
Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Bladder, Sexual Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity-based locomotor training
Arm Type
Experimental
Arm 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 Title
Activity-based stand training
Arm Type
Experimental
Arm 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 Title
Activity-based upper arm ergometry
Arm Type
Experimental
Arm 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(s)
Activity-based locomotor training
Other Intervention Name(s)
Locomotor training
Intervention 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).
Intervention Type
Procedure
Intervention Name(s)
Activity-based stand training
Other Intervention Name(s)
Stand training
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Activity-based upper arm ergometry
Other Intervention Name(s)
Arm Crank
Intervention Description
The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.
Primary Outcome Measure Information:
Title
Bladder Storage
Description
Bladder capacity (mlH2O)
Time Frame
5 years
Title
Bladder Emptying
Description
Voiding Efficiency (% voided)
Time Frame
5 years
Title
Bladder Pressure
Description
Leak point pressure (cmH2O)
Time Frame
5 years
Title
Compliance
Description
Bladder Compliance (ml/cmH2O)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF), Female Sexual function index (FSFI)
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Nitkin, PhD
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Study Director
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33278365
Citation
Hubscher CH, Wyles J, Gallahar A, Johnson K, Willhite A, Harkema SJ, Herrity AN. Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Arch Phys Med Rehabil. 2021 May;102(5):865-873. doi: 10.1016/j.apmr.2020.11.002. Epub 2020 Dec 3.
Results Reference
derived
PubMed Identifier
29385166
Citation
Hubscher CH, Herrity AN, Williams CS, Montgomery LR, Willhite AM, Angeli CA, Harkema SJ. Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One. 2018 Jan 31;13(1):e0190998. doi: 10.1371/journal.pone.0190998. eCollection 2018.
Results Reference
derived

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Recovery of Bladder and Sexual Function After Spinal Cord Injury

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