Recovery of Bladder and Sexual Function After Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT03036527
• Recruitment Status: Completed
• First Posted: January 30, 2017
• Last Update Posted: February 12, 2020
• Sponsor: University of Louisville
• Information provided by (Responsible Party): Susan Harkema, University of Louisville

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.

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Investigators

• Study Director: Ralph Nitkin, PhD; National Institutes of Health (NIH)

More Information

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

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.

• 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
• Last Update Posted: February 12, 2020
• Last Verified: February 2020

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:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System