Urinary Tract Infections
Conditions
Brief 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.
Interventions
DRUGCystoscopic Fluid containing Neosporin G. U. Irrigant
Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
PROCEDURECystoscopy
Diagnostic cystoscopy performed during pelvic floor surgery
DRUGCystoscopic Fluid/Placebo
Normal saline cystoscopic fluid
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tract Infection | 4 weeks | Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Standard cystoscopy with normal saline solution.
Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery
Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid | 111 |
| Neosporin G. U. Irrigant Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery | 105 |
| Total | 216 |
Baseline characteristics
| Characteristic | Standard Care | Neosporin G. U. Irrigant | Total |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 1 | 51.2 years STANDARD_DEVIATION 1.1 | 51.6 years STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized African American | 34 participants | 33 participants | 67 participants |
| Race/Ethnicity, Customized Latina | 12 participants | 12 participants | 24 participants |
| Race/Ethnicity, Customized Other | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 62 participants | 60 participants | 122 participants |
| Region of Enrollment United States | 111 participants | 105 participants | 216 participants |
| Sex: Female, Male Female | 111 Participants | 105 Participants | 216 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery Type (patients could have more than 1 procedure) Laparoscopic surgery | 41 participants | 45 participants | 86 participants |
| Surgery Type (patients could have more than 1 procedure) Midurethral sling | 62 participants | 46 participants | 108 participants |
| Surgery Type (patients could have more than 1 procedure) Uterosacral ligament suspension | 14 participants | 16 participants | 30 participants |
| Surgery Type (patients could have more than 1 procedure) Vaginal Hysterectomy | 79 participants | 68 participants | 147 participants |
| Surgery Type (patients could have more than 1 procedure) Vaginal native tissue repair | 19 participants | 14 participants | 33 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 105 |
| other Total, other adverse events | 0 / 111 | 0 / 105 |
| serious Total, serious adverse events | 0 / 111 | 0 / 105 |
Outcome results
Primary
Urinary Tract Infection
Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Urinary Tract Infection | 11 UTI |
| Neosporin G. U. Irrigant | Urinary Tract Infection | 12 UTI |