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NCT06163469 · ClinicalTrials.gov registry record · NA
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
A NA study of Neurogenic Bladder and Urinary Retention, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06163469: Recruiting NA study of Neurogenic Bladder and Urinary Retention, sponsored by Yale University.
NCT06163469 is a NA study of Neurogenic Bladder and Urinary Retention that is actively recruiting participants, run by Yale University. The registered enrollment target is 70 participants, below the 89-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (21% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06163469, a NA study of Neurogenic Bladder and Urinary Retention, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are: 1. is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients. 2. does this protocol decrease the rate of unplanned health care visits and improve patient quality of life. Patients will undergo the treatment protocol during their routine suprapubic catheter exchanges.
Primary Outcome
Tolerability and feasibility of CGH bladder instillation of 150mL for five-minute duration at the time of SPC exchange. Volumes of each instillation and tolerated dwell time will be recorded with each instillation.
Conditions Studied
Interventions
- DEVICE Bladder instillation with Irrisept
Study Locations (1)
Connecticut
- Yale New Haven Health - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT06163469 shows while recruiting
NCT06163469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 89-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (21% lower).
The record links to 2 conditions, with Neurogenic Bladder appearing as the primary indexed condition, and to 1 intervention - of which Bladder instillation with Irrisept is the first listed.
NCT06163469 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06163469 about?
NCT06163469 is a clinical study titled "Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life". The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main quest...
What is the current status of trial NCT06163469?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2024-04-01. Estimated completion is 2025-12-31.
What conditions does trial NCT06163469 study?
This clinical trial studies the following conditions: Neurogenic Bladder, Urinary Retention.
What interventions are being tested in trial NCT06163469?
The interventions under investigation include: Bladder instillation with Irrisept (DEVICE).
Who is sponsoring clinical trial NCT06163469?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06163469 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06163469's enrollment target sits among peer trials
70 6th of 16 higher than 11 of 16 other Neurogenic Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurogenic Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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