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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099863
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Mangel, MetroHealth Medical Center

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant Procedure: Cystoscopy Drug: Cystoscopic Fluid/Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

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Arm Intervention/treatment
Placebo Comparator: Standard Care
Standard cystoscopy with normal saline solution.
Procedure: Cystoscopy
Diagnostic cystoscopy performed during pelvic floor surgery

Drug: Cystoscopic Fluid/Placebo
Normal saline cystoscopic fluid

Active Comparator: Neosporin G. U. Irrigant
Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant
Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL

Procedure: Cystoscopy
Diagnostic cystoscopy performed during pelvic floor surgery




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099863


Locations
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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
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Responsible Party: Jeffrey Mangel, Physician, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03099863    
Other Study ID Numbers: IRB15-00769
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents