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Spinal Cord InjuriesNCT03036527

Recovery of Bladder and Sexual Function After Spinal Cord Injury

A study testing Activity-based locomotor training, Activity-based stand training and Activity-based upper arm ergometry in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Activity-based locomotor training, Activity-based stand training and Activity-based upper arm ergometry
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Sep 2014to Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Louisville

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Activity-based locomotor training, Activity-based stand training, Activity-based upper arm ergometry, Activity-based training + spinal epidural stimulation
Keywords
Bladder, Sexual Function
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity-based locomotor trainingProcedure or surgery

    Also called 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).

  • Activity-based stand trainingProcedure or surgery

    Also called 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.

  • Activity-based upper arm ergometryProcedure or surgery

    Also called Arm Crank

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

  • Activity-based training + spinal epidural stimulationProcedure or surgery

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

Study groups in NCT03036527
Study groupRoleWhat they receive
Activity-based locomotor trainingExperimentalTo 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.
Receives: Procedure: Activity-based locomotor training
Activity-based stand trainingExperimentalTo 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.
Receives: Procedure: Activity-based stand training
Activity-based upper arm ergometryExperimentalTo 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.
Receives: Procedure: Activity-based upper arm ergometry
Activity based training + spinal epidural stimulationExperimentalcombination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
Receives: Procedure: Activity-based locomotor training; Procedure: Activity-based stand training; Procedure: Activity-based training + spinal epidural stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder Storage

    Bladder capacity (mlH2O)

    Measured: 5 years, 2 months

  2. Bladder Emptying

    Voiding Efficiency (% voided)

    Measured: 5 years, 2 months

  3. Bladder Pressure

    Leak point pressure (cmH2O)

    Measured: 5 years, 2 months

  4. Compliance

    Bladder Compliance (ml/cmH2O)

    Measured: 5 years, 2 months

Secondary outcomes (1)

  1. International Index of Erectile Function (IIEF)

    There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction.

    Scoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes.

    Overall IIEF score range is 5-75; total >61.8 considered normal.

    Measured: 5 years, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2017 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2019
  4. Study completionNov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03036527
Sponsor's protocol ID
14.0062 Bladder Sex Fxn
Other IDs
5R01HD080205
Status last verified
Jun 2024
First submitted
9 Jan 2017
Last updated
13 Jun 2024
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 33278365

  • 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.

    PubMed 29385166

Questions about this trial

What is this clinical trial studying?

A study testing Activity-based locomotor training, Activity-based stand training and Activity-based upper arm ergometry in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder Storage (time frame: 5 years, 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036527, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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