Recovery of Bladder and Sexual Function After Spinal Cord Injury

NCT03036527 | Completed Results DMC

• 2 other identifiers: 14.0062 Bladder Sex Fxn5R01HD080205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Bladder; Sexual Function

Outcome Measures

Primary Outcomes (4)

• Bladder Storage

  Bladder capacity (mlH2O)

  5 years, 2 months

• Bladder Emptying

  Voiding Efficiency (% voided)

  5 years, 2 months

• Bladder Pressure

  Leak point pressure (cmH2O)

  5 years, 2 months

• Compliance

  Bladder Compliance (ml/cmH2O)

  5 years, 2 months

Secondary Outcomes (1)

• International Index of Erectile Function (IIEF)

  5 years, 2 months

Study Arms (4)

Activity-based locomotor training

EXPERIMENTAL

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

Activity-based stand training

EXPERIMENTAL

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

Activity-based upper arm ergometry

EXPERIMENTAL

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

Activity based training + spinal epidural stimulation

EXPERIMENTAL

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Procedure: Activity-based locomotor training; Procedure: Activity-based stand training; Procedure: Activity-based training + spinal epidural stimulation

Interventions

Activity-based locomotor training PROCEDURE

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).

Also known as: Locomotor training

Activity based training + spinal epidural stimulation; Activity-based locomotor training

Activity-based stand training PROCEDURE

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.

Also known as: Stand training

Activity based training + spinal epidural stimulation; Activity-based stand training

Activity-based upper arm ergometry PROCEDURE

The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.

Also known as: Arm Crank

Activity-based upper arm ergometry

Activity-based training + spinal epidural stimulation PROCEDURE

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Activity based training + spinal epidural stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (2)

• 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.

  PMID: 33278365 DERIVED

• 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.

  PMID: 29385166 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Charles Hubscher
• Organization: University of Louisville

charles.hubscher@louisville.edu

502-852-3058

Study Officials

• Ralph Nitkin, PhD

  National Institutes of Health (NIH)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 30, 2017
• Study Start: September 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)