Phase 4
N=242
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT03099863 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Urinary Tract Infection — 11; 12 UTI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cystoscopic Fluid containing Neosporin G. U. Irrigant (Drug); Cystoscopy (Procedure); Cystoscopic Fluid/Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Tract Infection |
11; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult women at least 18 years of age
- Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy.
Exclusion Criteria
- Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
- Pregnancy
- History of nephrolithiasis
- Allergy to study medications
- Congenital urogenital anomaly
- Neurogenic bladder
Data sourced from ClinicalTrials.gov (NCT03099863). 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.