search
Back to results

Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Primary Purpose

Infection Associated With Catheter, Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
silver SPC
standard SPC
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection Associated With Catheter focused on measuring CAUTI, UTI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

silver SPC

standard SPC

Arm Description

Subjects randomized to receive silver-impregnated SPC.

subjects randomized to receive standard SPC.

Outcomes

Primary Outcome Measures

Urinary Tract Infection Rate
Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria.

Secondary Outcome Measures

Risk of Urinary Tract Infections in Diabetics
Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.

Full Information

First Posted
May 20, 2011
Last Updated
April 25, 2019
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01359046
Brief Title
Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology
Official Title
Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Associated With Catheter, Urinary Tract Infection
Keywords
CAUTI, UTI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silver SPC
Arm Type
Experimental
Arm Description
Subjects randomized to receive silver-impregnated SPC.
Arm Title
standard SPC
Arm Type
Active Comparator
Arm Description
subjects randomized to receive standard SPC.
Intervention Type
Device
Intervention Name(s)
silver SPC
Intervention Description
subject randomized to receive silver alloy impregnated catheter
Intervention Type
Device
Intervention Name(s)
standard SPC
Intervention Description
subject randomized to receive standard catheter
Primary Outcome Measure Information:
Title
Urinary Tract Infection Rate
Description
Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria.
Time Frame
within 6 weeks post surgery
Secondary Outcome Measure Information:
Title
Risk of Urinary Tract Infections in Diabetics
Description
Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.
Time Frame
within 6 weeks post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Gebhart, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30145671
Citation
Singh R, Hokenstad ED, Wiest SR, Kim-Fine S, Weaver AL, McGree ME, Klingele CJ, Trabuco EC, Gebhart JB. Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients. Int Urogynecol J. 2019 May;30(5):779-787. doi: 10.1007/s00192-018-3726-z. Epub 2018 Aug 25.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

We'll reach out to this number within 24 hrs