Recovery of Bladder and Sexual Function After Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT03036527 |
Recruitment Status :
Completed
First Posted : January 30, 2017
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries | Procedure: Activity-based locomotor training Procedure: Activity-based stand training Procedure: Activity-based upper arm ergometry | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | November 2019 |
Actual Study Completion Date : | November 2019 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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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 |
- Bladder Storage [ Time Frame: 5 years ]Bladder capacity (mlH2O)
- Bladder Emptying [ Time Frame: 5 years ]Voiding Efficiency (% voided)
- Bladder Pressure [ Time Frame: 5 years ]Leak point pressure (cmH2O)
- Compliance [ Time Frame: 5 years ]Bladder Compliance (ml/cmH2O)
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Study Director: | Ralph Nitkin, PhD | National Institutes of Health (NIH) |
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 |
Other Study ID Numbers: |
14.0062 Bladder Sex Fxn |
First Posted: | January 30, 2017 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Bladder Sexual Function |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |