Silver-Coated vs Standard Catheter for UTI Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery

Secondary Aims:

To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study

NCT00554996

Urinary Tract Infection

COMPLETED PHASE1

Foley Catheter vs a Self-contained Valved Urinary Catheter

NCT03178734

COMPLETED NA

Urinary Track Infection Prevention After Urogynecological Surgery

NCT03818321

Urinary Tract Infections Urinary Retention Postoperative Pelvic Organ Prolapse

COMPLETED PHASE2

Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

NCT03287089

Catheter-Associated Urinary Tract Infection

COMPLETED PHASE4

A Prospective Analysis of Biofilm in Urinary Catheters Study

NCT01987336

Urinary Incontinence

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

UTI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Silver-Coated Catheter

Group Type ACTIVE_COMPARATOR

2-Way Foley Urethral Urinary Catheter

Intervention Type DEVICE

Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Standard Catheter

Group Type PLACEBO_COMPARATOR

2-Way Foley Urethral Urinary Catheter

Intervention Type DEVICE

Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2-Way Foley Urethral Urinary Catheter

Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.

Exclusion Criteria

* Unwilling or unable to participate in the study.
* Unwilling or unable to do a catheter self-removal at home.
* Inability to understand English.
* Pregnant women
* Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
* Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
* Active urinary tract infection.
* Intraoperative bladder injury or cystotomy
* Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms
* Reported allergy to silver metal

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No