Clinical trial NCT01243125: Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
Official title: A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Catheter Blockage and Encrustation
Keywords: Blockage
Encrustation
Catheter
Spinal Cord Injury
SCI
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
* Screening within 30 days of first treatment

Exclusion Criteria:

* Systemic antibiotics within 7 days of first treatment
* Investigational drug or device within 30 days of enrollment
* Current infection that requires treatment with systemic antibiotics
* Recent history of significant autonomic dysreflexia (requiring intervention or treatment)

Primary outcomes:
measure: Catheter patency following treatment
timeFrame: 26 days
Secondary outcomes:
measure: Incidence of catheter blockage requiring early removal
timeFrame: 26 days
measure: Assessment of biofilm of catheter
timeFrame: 26 days
measure: Assessment of encrustation of catheter
timeFrame: 26 days
Other outcomes:
Locations:
city: Downey
country: United States
facility: Los Amigos Research and Education Institute (LAREI)
state: California
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
Study officials:
affiliation: NovaBay Pharmaceuticals / kkrantz@novabaypharma.com
name: Kenneth D. Krantz, MD, PhD
role: STUDY_DIRECTOR
References: