Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms

MedStar Health

Status: Enrolling

Conditions: Neurogenic Lower Urinary Tract Dysfunction; Spinal Cord Injuries; Neurogenic Bladder

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07390591

STUDY00009066

CDMRP-SC230144P1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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