Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

NCT03099863 | Completed Phase 4 Results DMC

• 1 other identifier: IRB15-00769
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Urinary Tract Infection

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

  4 weeks

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Standard cystoscopy with normal saline solution.

Procedure: Cystoscopy; Drug: Cystoscopic Fluid/Placebo

Neosporin G. U. Irrigant

ACTIVE COMPARATOR

Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.

Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Procedure: Cystoscopy

Interventions

Cystoscopic Fluid containing Neosporin G. U. Irrigant DRUG

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

Neosporin G. U. Irrigant

Cystoscopy PROCEDURE

Diagnostic cystoscopy performed during pelvic floor surgery

Neosporin G. U. Irrigant; Standard Care

Cystoscopic Fluid/Placebo DRUG

Normal saline cystoscopic fluid

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
• Pregnancy
• History of nephrolithiasis
• Allergy to study medications
• Congenital urogenital anomaly
• Neurogenic bladder

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Limitations and Caveats

Our primary limitation is the failure to reach statistical power based on the lower than expected incidence of UTI. Additionally, our patient cohort had a wide variation in surgical approach and techniques, which have different UTI risks at baseline. The total cohort is underpowered to identify differences in any one procedure type, such as vaginal reconstruction or mid-urethral slings.

Results Point of Contact

• Title: Dr. Jeffrey Mangel
• Organization: MetroHealth Medical Center

jmangel@metrohealth.org

2167784444

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 4, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 30, 2021
• Results First Posted: December 30, 2021

Record last verified: 2021-12

Locations

US (1)