Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
Public ClinicalTrials.gov record NCT01243125. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others. The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life. The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage. Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.
Study identification
- NCT ID
- NCT01243125
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 67 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Jun 30, 2013
- Completion
- Jul 31, 2013
- Last update posted
- Aug 6, 2014
2010 – 2013
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Amigos Research and Education Institute (LAREI) | Downey | California | 90242 | — |
| Specialists in Urology | Naples | Florida | 34102 | — |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | — |
| Integrity Medical Research | Mountlake Terrace | Washington | 98043 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01243125, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2014 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01243125 live on ClinicalTrials.gov.