- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036527
Recovery of Bladder and Sexual Function After Spinal Cord Injury
February 11, 2020 updated by: Susan Harkema, 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
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)
30
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
-
-
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
No
Genders Eligible for Study
All
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bladder Storage
Time Frame: 5 years
|
Bladder capacity (mlH2O)
|
5 years
|
Bladder Emptying
Time Frame: 5 years
|
Voiding Efficiency (% voided)
|
5 years
|
Bladder Pressure
Time Frame: 5 years
|
Leak point pressure (cmH2O)
|
5 years
|
Compliance
Time Frame: 5 years
|
Bladder Compliance (ml/cmH2O)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
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
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 (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.0062 Bladder Sex Fxn
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.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Epidural Spinal Cord CompressionUnited States
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
Clinical Trials on Activity-based locomotor training
-
University of FloridaBaylor College of Medicine; The Craig H. Neilsen Foundation; Brooks RehabilitationCompletedSpinal Cord Injury (SCI)United States
-
Allina Health SystemTerminatedSpinal Cord InjuriesUnited States
-
Baylor UniversityEnrolling by invitationCerebral PalsyUnited States
-
Baylor UniversityRecruitingCerebral PalsyUnited States
-
Hugo W. Moser Research Institute at Kennedy Krieger...Terminated
-
US Department of Veterans AffairsCompletedSeated Treadmill Training | Treadmill Locomotor-based Training | Treadmill OnlyUnited States
-
National Institute of Neurological Disorders and...Completed
-
University of MiamiEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSpinal Cord Injury
-
Stony Brook UniversityOhio State University; University of Louisville; TIRR Memorial Hermann; Kessler... and other collaboratorsCompletedSpinal Cord Injuries | Spinal Cord TraumaUnited States
-
US Department of Veterans AffairsCompleted