Trial Outcomes & Findings for Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection (NCT NCT03099863)

NCT ID: NCT03099863

Last Updated: 2021-12-30

Results Overview

Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 242 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2021-12-30

Participant Flow

Participant milestones

Measure	Standard Care Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid	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
Overall Study STARTED	121	121
Overall Study COMPLETED	111	105
Overall Study NOT COMPLETED	10	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All participants were analyzed

Baseline characteristics by cohort

Measure	Standard Care n=111 Participants Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid	Neosporin G. U. Irrigant n=105 Participants 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	Total n=216 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 1.0 • n=5 Participants	51.2 years STANDARD_DEVIATION 1.1 • n=7 Participants	51.6 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	105 Participants n=7 Participants	216 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	62 participants n=5 Participants • All participants were analyzed	60 participants n=7 Participants • All participants were analyzed	122 participants n=5 Participants • All participants were analyzed
Race/Ethnicity, Customized African American	34 participants n=5 Participants • All participants were analyzed	33 participants n=7 Participants • All participants were analyzed	67 participants n=5 Participants • All participants were analyzed
Race/Ethnicity, Customized Latina	12 participants n=5 Participants • All participants were analyzed	12 participants n=7 Participants • All participants were analyzed	24 participants n=5 Participants • All participants were analyzed
Race/Ethnicity, Customized Other	3 participants n=5 Participants • All participants were analyzed	0 participants n=7 Participants • All participants were analyzed	3 participants n=5 Participants • All participants were analyzed
Region of Enrollment United States	111 participants n=5 Participants	105 participants n=7 Participants	216 participants n=5 Participants
Surgery Type (patients could have more than 1 procedure) Vaginal Hysterectomy	79 participants n=5 Participants	68 participants n=7 Participants	147 participants n=5 Participants
Surgery Type (patients could have more than 1 procedure) Uterosacral ligament suspension	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Surgery Type (patients could have more than 1 procedure) Vaginal native tissue repair	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants
Surgery Type (patients could have more than 1 procedure) Midurethral sling	62 participants n=5 Participants	46 participants n=7 Participants	108 participants n=5 Participants
Surgery Type (patients could have more than 1 procedure) Laparoscopic surgery	41 participants n=5 Participants	45 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.

Outcome measures

Measure	Standard Care n=111 Participants Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid	Neosporin G. U. Irrigant n=105 Participants 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
Urinary Tract Infection	11 UTI Interval 4.0 to 16.0	12 UTI Interval 5.0 to 18.0

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neosporin G. U. Irrigant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Mangel

MetroHealth Medical Center

Phone: 2167784444

Email: jmangel@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place