CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 242 enrolled
Drug / intervention
Cystoscopic Fluid containing Neosporin G. U. Irrigant +2 moredrug
Likely dose
Cystoscopic Fluid containing Neosporin G. U. Irrigant 1mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03099863
NCT03099863Phase 4Completed
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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study

MetroHealth Medical Center·interventional·Posted Apr 4, 2017·Updated Dec 30, 2021

In Brief

A Phase 4 clinical trial evaluating Cystoscopic Fluid containing Neosporin G. U. Irrigant, Cystoscopy, and 1 other intervention for Urinary Tract Infections. Completed, enrolled 242 participants across 1 site.

Detailed Summary

Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartApr 1, 2016
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.2 years ago

Interventions

Cystoscopic Fluid containing Neosporin G. U. Irrigantdrug

Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL

Cystoscopyprocedure

Diagnostic cystoscopy performed during pelvic floor surgery

Cystoscopic Fluid/Placebodrug

Normal saline cystoscopic fluid