N/A
N=288
Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology
Infection Associated With Catheter · Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01359046 ↗Enrolled (actual)
288
Serious AEs
2.3%
Results posted
Apr 2019
Primary outcome: Primary: Urinary Tract Infection Rate — 24; 29 Participants — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- silver SPC (Device); standard SPC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Tract Infection Rate |
24; 29 | 0.30 |
| SECONDARY Risk of Urinary Tract Infections in Diabetics |
4; 8 | 0.68 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01359046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.