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OpenTrials
Completed

NCT Number: NCT03099863

Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cystoscopic Fluid containing Neosporin G. U. Irrigant

Drug

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

cystoscopy

Procedure

Diagnostic cystoscopy performed during pelvic floor surgery

Cystoscopic Fluid/Placebo

Drug

Normal saline cystoscopic fluid

Primary outcomes

  1. Urinary Tract Infection

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2017
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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