Spinal Cord InjuriesNCT07390591
Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms
An observational study of Spinal Cord Injuries and Neurogenic Lower Urinary Tract Dysfunction, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Lower Urinary Tract Dysfunction, Neurogenic Bladder
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from populations that have used Lactobacillus, gentamicin, or combination of the two.
Who may be able to join
- Criteria for patients:
- Age 18+
- Diagnosis of NLUTD
- Chronic catheter usage (minimum 6 months), either intermittent catheterization or indwelling catheter
- Community-dwelling
- Experience using intravesical Lactobacillus, gentamicin, or combination of the two
Show all 11Show fewer
- Criteria for caregivers:
- Age 18+
- Care for patient with diagnosis of NLUTD
- Care for patient who has used catheters chronically (minimum 6 months)
- Experience facilitating patients' use of intravesical Lactobacillus, gentamicin, or combination of the two
Who cannot join
- Psychiatric or psychologic conditions impacting ability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medstar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Christopher Riegner, MPH, 202-892-5857, Christopher.R.Riegner@medstar.net
Inger Ljungberg, MPH, Inger.H.Ljungberg@medstar.net
About this study
Official title: Intravesical Gentamicin Coupled With Lactobacillus Rhamnosus for Urinary Health- Early Career
The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. The study aims to understand the perceived benefits, challenges, and opportunities related to Lactobacillus-only, gentamicin-only, and combined gentamicin-Lactobacillus instillations. The main question this study seeks to answer is:
- Determine patient and caregivers' preferences, and overall experiences regarding intravesical therapeutics for urinary symptoms and UTI
Read more
Researchers will compare responses from four groups: participants who have used Lactobacillus-only instillations, gentamicin-only instillations, combined gentamicin-Lactobacillus instillations, and caregivers who have experience supporting instillations.
Participants will take part in a one-hour semi-structured interview and may be contacted for brief follow-up discussions to clarify findings. Interviews will be audio-recorded, transcribed, and analyzed using qualitative data software to identify themes related to treatment preferences and acceptability.
Read the detailed description
Participants in this study will engage in an in-depth qualitative semi-structured interview process designed to explore their experiences with intravesical instillation practices. Each participant will complete a one-hour interview, during which they will be asked about their personal routines, decision-making factors, and perceptions related to bladder instillations. To ensure accuracy of interpretation, participants may also be invited to take part in brief follow-up discussions lasting no more than 30 minutes each. These follow-up interactions will occur within 12 months of the initial interview, and the total participation time will not exceed 2.5 hours over the study period.
All interviews will be audio-recorded, transcribed, reviewed for accuracy, and analyzed using a secure, cloud-based qualitative data analysis platform that allows linked review of audio and transcript files. Interviews will continue until data saturation is reached, meaning no new concepts emerge from additional participants.
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Advancing intravesical instillation for urinary health
Qualitative interviews will be coded, and themes how to advance intravesical instillation for urinary health will emerge.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start19 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Ana Valeria Aguirre Guemez, MD, Principal investigator, MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390591
- Sponsor's protocol ID
- STUDY00009066
- Other IDs
- CDMRP-SC230144P1
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Gentamicin Coupled With Lactobacillus Rhamnosus for Urinary Health- Early Career
- ClinicalTrials.gov ID
- NCT07390591
- Acronym / sponsor ID
- STUDY00009066
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. The study aims to understand the perceived benefits, challenges, and opportunities related to Lactobacillus-only, gentamicin-only, and combined gentamicin-Lactobacillus instillations. The main question this study seeks to answer is:
- Determine patient and caregivers' preferences, and overall experiences regarding intravesical therapeutics for urinary symptoms and UTI
Researchers will compare responses from four groups: participants who have used Lactobacillus-only instillations, gentamicin-only instillations, combined gentamicin-Lactobacillus instillations, and caregivers who have experience supporting instillations.
Participants will take part in a one-hour semi-structured interview and may be contacted for brief follow-up discussions to clarify findings. Interviews will be audio-recorded, transcribed, and analyzed using qualitative data software to identify themes related to treatment preferences and acceptability.
Detailed description
Participants in this study will engage in an in-depth qualitative semi-structured interview process designed to explore their experiences with intravesical instillation practices. Each participant will complete a one-hour interview, during which they will be asked about their personal routines, decision-making factors, and perceptions related to bladder instillations. To ensure accuracy of interpretation, participants may also be invited to take part in brief follow-up discussions lasting no more than 30 minutes each. These follow-up interactions will occur within 12 months of the initial interview, and the total participation time will not exceed 2.5 hours over the study period.
All interviews will be audio-recorded, transcribed, reviewed for accuracy, and analyzed using a secure, cloud-based qualitative data analysis platform that allows linked review of audio and transcript files. Interviews will continue until data saturation is reached, meaning no new concepts emerge from additional participants.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from populations that have used Lactobacillus, gentamicin, or combination of the two.
Key inclusion criteria (11 listed)
- Age 18+
- Diagnosis of NLUTD
- Chronic catheter usage (minimum 6 months), either intermittent catheterization or indwelling catheter
- Community-dwelling
- Experience using intravesical Lactobacillus, gentamicin, or combination of the two
Key exclusion criteria (1 listed)
- Psychiatric or psychologic conditions impacting ability to consent
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
Advancing intravesical instillation for urinary health
Time frame: 12 months
Qualitative interviews will be coded, and themes how to advance intravesical instillation for urinary health will emerge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
Ana Valeria Aguirre Guemez, MD principal investigator
MedStar National Rehabilitation Hospital
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 Spinal Cord Injuries and Neurogenic Lower Urinary Tract Dysfunction, run by Medstar Health Research Institute 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 11 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Riegner, MPH (202-892-5857, Christopher.R.Riegner@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advancing intravesical instillation for urinary health (time frame: 12 months). 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 5 Feb 2026.