Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms

NCT07390591 | Recruiting

• 2 other identifiers: STUDY00009066CDMRP-SC230144P1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Advancing intravesical instillation for urinary health

  Qualitative interviews will be coded, and themes how to advance intravesical instillation for urinary health will emerge.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Psychiatric or psychologic conditions impacting ability to consent

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Medstar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Valeria Aguirre Guemez, MD

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Riegner, MPH

CONTACT

202-892-5857; Christopher.R.Riegner@medstar.net

Inger Ljungberg, MPH

CONTACT

202-877-1694; Inger.H.Ljungberg@medstar.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 5, 2026
• Study Start: June 19, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)