Urinary Bladder, NeurogenicNCT04193709
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
An observational study of Urinary Bladder, Neurogenic and Blood Pressure, run by University of Louisville at 1 site in United States.
Trial summary
This study will incorporate critical cross viscero-visceral intersystem interactions to investigate in a controlled laboratory setting the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 24 Apr 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal cord injury and neurogenic bladder and bowel dysfunction
Who may be able to join
- At least 18 years of age;
- AIS A to D;
- Neurogenic bladder and bowel dysfunction;
- Stable medical condition
Who cannot join
- Prior Botox injections of the bladder and/or bladder augmentation surgery;
- Colostomy bag,
- Ventilator dependent;
- Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
- Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
This study will incorporate critical cross viscero-visceral intersystem interactions to investigate in a controlled laboratory setting the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function.
- Medical subject headings
- Urinary Bladder, Neurogenic, Autonomic Dysreflexia, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Measure blood pressure during bladder filling and bowel stimulation | The purpose of this arm is to systematically measure changes in systolic blood pressure and symptomatic indices of autonomic nervous system activation in persons with spinal cord injuries during bladder filling and anorectal manometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Participants With Change in Systolic Blood Pressure Above 20 mmHg During Bladder Filling
Will determine % participants with change in systolic blood pressure above 20 mmHg during bladder filling. Changes in systolic blood pressure is measured as bladder is filled during cystometry.
Measured: 2 hours
% Participants With Change in Systolic Blood Pressure Above 20 mmHg During Filling During Anorectal Manometry Assessments
Will determine % participants with change in systolic blood pressure above 20 mmHg during bowel stimulation. Changes in systolic blood pressure is measured as bowel is inserted, moved, distended, expulsion (attempt) and removed (if not expelled with attempt) during anorectal manometry.
Measured: 1 hour
Secondary outcomes (2)
Will Determine % Participants With Symptomatic Indices During Bladder Filling
To determine the % participants showing one or more symptoms of autonomic dysreflexia during bladder filling (cystometry)
Measured: 2 hours
19.1194 Will Determine % Participants With Symptomatic Indices During Bowel Stimulation
To determine the % participants showing one or more symptoms of autonomic dysreflexia during bowel stimulation (anorectal manometry)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start4 Jan 2021
- Primary completion9 Apr 2025
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Bladder, NeurogenicStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Charles Hubscher, University of Louisville
- Investigators
- Charles Hubscher, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193709
- Sponsor's protocol ID
- 19.1194
- Other IDs
- 5R01HD080205
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2019
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04193709
- Acronym / sponsor ID
- 19.1194
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will incorporate critical cross viscero-visceral intersystem interactions to investigate in a controlled laboratory setting the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measure blood pressure during bladder filling and bowel stimulation | – | –The purpose of this arm is to systematically measure changes in systolic blood pressure and symptomatic indices of autonomic nervous system activation in persons with spinal cord injuries during bladder filling and anorectal manometry. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injury and neurogenic bladder and bowel dysfunction
Key inclusion criteria (4 listed)
- At least 18 years of age;
- AIS A to D;
- Neurogenic bladder and bowel dysfunction;
- Stable medical condition
Key exclusion criteria (5 listed)
- Prior Botox injections of the bladder and/or bladder augmentation surgery;
- Colostomy bag,
- Ventilator dependent;
- Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
- Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% Participants With Change in Systolic Blood Pressure Above 20 mmHg During Bladder Filling
Time frame: 2 hours
Will determine % participants with change in systolic blood pressure above 20 mmHg during bladder filling. Changes in systolic blood pressure is measured as bladder is filled during cystometry.
% Participants With Change in Systolic Blood Pressure Above 20 mmHg During Filling During Anorectal Manometry Assessments
Time frame: 1 hour
Will determine % participants with change in systolic blood pressure above 20 mmHg during bowel stimulation. Changes in systolic blood pressure is measured as bowel is inserted, moved, distended, expulsion (attempt) and removed (if not expelled with attempt) during anorectal manometry.
2 secondary outcomes
Will Determine % Participants With Symptomatic Indices During Bladder Filling
Time frame: 2 hours
19.1194 Will Determine % Participants With Symptomatic Indices During Bowel Stimulation
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hubscher, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Neurogenic and Blood Pressure, 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 4 inclusion and 5 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 29 Oct 2026. 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 29 Oct 2026). 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?
% Participants With Change in Systolic Blood Pressure Above 20 mmHg During Bladder Filling (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.