Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms

January 28, 2026 updated by: Medstar Health Research Institute

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:

1. 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from populations that have used Lactobacillus, gentamicin, or combination of the two.

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

  • Psychiatric or psychologic conditions impacting ability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Ana Valeria Aguirre Guemez, MD, MedStar National Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009066
  • CDMRP-SC230144P1 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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