Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

NCT01305681 | Withdrawn Phase 1

• 1 other identifier: IRB10-00458
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of our study is to examine characteristics of bacteria that are discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric® catheters for self intermittent catheterization. The investigators hypothesize that the hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce clinically significant urinary tract infections in patients with neurogenic bladder compared to a similar population using standard catheters. Secondary outcomes will be comparing the incidence of clinical urinary tract infections between patients that use standard catheters and those that use LoFric catheters. Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be assessed.

Conditions

Neurogenic Bladder; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization

  18 months

Study Arms (1)

LoFric® catheters

ACTIVE COMPARATOR

LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization

Device: LoFric® catheters during clean intermittent catheterization

Interventions

LoFric® catheters during clean intermittent catheterization DEVICE

LoFric® catheters during clean intermittent catheterization

LoFric® catheters

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who perform clean intermittent catheterization on a regular basis

You may not qualify if:

• Patients on daily continuous antibiotic therapy

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; 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; Urination Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Please close this study at ct.gov as we have not further data at NCH as Dr. Vanderbrink left NCH in 2011.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful. The study expired with the NCH IRB before it was ever approved for a 2nd year.

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: May 6, 2011
• Primary Completion: February 21, 2012
• Study Completion: February 21, 2012
• Last Updated: August 7, 2019

Record last verified: 2011-11

Locations

US (1)