Patient and caregiver perspectives on bladder instillations for urinary symptoms
Intravesical Gentamicin Coupled With Lactobacillus Rhamnosus for Urinary Health- Early Career
This project talks with adults who have neurogenic bladder and their caregivers to see what they prefer and experience with bladder instillations of Lactobacillus, gentamicin, or both.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07390591 on ClinicalTrials.gov |
What this trial studies
This observational qualitative project uses one-hour semi-structured interviews with adults with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers to explore experiences with intravesical Lactobacillus-only, gentamicin-only, and combined instillations. Participants may be invited to brief follow-up discussions within 12 months, with total participation time capped at 2.5 hours. Interviews are audio-recorded, transcribed, and analyzed using a secure cloud-based qualitative analysis platform, and recruitment will continue until thematic saturation is reached. Responses from four groups—Lactobacillus-only users, gentamicin-only users, combined users, and caregivers—will be compared to identify preferences, perceived benefits, and barriers.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with NLUTD who have used chronic catheters for at least six months and have personal experience receiving intravesical Lactobacillus, gentamicin, or both, as well as caregivers who have facilitated those instillations.
Not a fit: People without prior experience with these intravesical treatments, those not community-dwelling, or those unable to provide informed consent due to psychiatric conditions are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help align instillation approaches with patient preferences, improving comfort, adherence, and potentially reducing infection risk.
How similar studies have performed: Some clinical studies have shown intravesical antibiotics can reduce urinary infections, but qualitative research on patient and caregiver views specifically about Lactobacillus and gentamicin instillations is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia
- Medstar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Ana Valeria Aguirre Guemez, MD — MedStar National Rehabilitation Hospital
- Study coordinator: Christopher Riegner, MPH
- Email: Christopher.R.Riegner@medstar.net
- Phone: 202-892-5857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.