Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

NCT01359046 | Completed Results

• 1 other identifier: 10-007421
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection Associated With Catheter; Urinary Tract Infection

Keywords

CAUTI; UTI

Outcome Measures

Primary Outcomes (1)

• 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.

  within 6 weeks post surgery

Secondary Outcomes (1)

• Risk of Urinary Tract Infections in Diabetics

  within 6 weeks post surgery

Study Arms (2)

silver SPC

EXPERIMENTAL

Subjects randomized to receive silver-impregnated SPC.

Device: silver SPC

standard SPC

ACTIVE COMPARATOR

subjects randomized to receive standard SPC.

Device: standard SPC

Interventions

silver SPC DEVICE

subject randomized to receive silver alloy impregnated catheter

silver SPC

standard SPC DEVICE

subject randomized to receive standard catheter

standard SPC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 30145671 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Catheter-Related Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John Gebhart
• Organization: Mayo Clinic

gebhart.john@mayo.edu

507-266-7711

Study Officials

• John Gebhart, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: July 1, 2011
• Primary Completion: March 2, 2018
• Study Completion: March 9, 2018
• Last Updated: May 9, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Locations

US (1)