Intravesical Gentamicin Coupled With Lactobacillus Rhamnosus for Urinary Health- Early Career
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Advancing intravesical instillation for urinary health
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for patients:
- •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:
- •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
排除标准
- •Psychiatric or psychologic conditions impacting ability to consent
结局指标
主要结局
Advancing intravesical instillation for urinary health
时间窗: 12 months
Qualitative interviews will be coded, and themes how to advance intravesical instillation for urinary health will emerge.
次要结局
未报告次要终点