Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2018-03-09

Brief Summary

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The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

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Detailed Description

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Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.

There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections.

Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

Conditions

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Infection Associated With Catheter Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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silver SPC

Subjects randomized to receive silver-impregnated SPC.

Group Type EXPERIMENTAL

silver SPC

Intervention Type DEVICE

subject randomized to receive silver alloy impregnated catheter

standard SPC

subjects randomized to receive standard SPC.

Group Type ACTIVE_COMPARATOR

standard SPC

Intervention Type DEVICE

subject randomized to receive standard catheter

Interventions

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silver SPC

subject randomized to receive silver alloy impregnated catheter

Intervention Type DEVICE

standard SPC

subject randomized to receive standard catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, Burch colposuspension, with or without mid-urethral sling

Exclusion Criteria

* Known UTI at time of surgery
* Unable to provide informed consent
* Use of chronic intermittent self-catheterization pre-operatively
* Use of chronic prophylactic antibiotics
* Use of antibiotics for any indication other than UTI during peri-operative and 6-week post-operative period
* Presence of fistula involving urogenital tract
* Use of chronic steroids or immunosuppressant
* Immunocompromised patient

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No