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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

NCT ID: NCT03099863

Last Updated: 2021-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard Care

Standard cystoscopy with normal saline solution.

Group Type PLACEBO_COMPARATOR

Cystoscopy

Intervention Type PROCEDURE

Diagnostic cystoscopy performed during pelvic floor surgery

Cystoscopic Fluid/Placebo

Intervention Type DRUG

Normal saline cystoscopic fluid

Neosporin G. U. Irrigant

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

Group Type ACTIVE_COMPARATOR

Cystoscopic Fluid containing Neosporin G. U. Irrigant

Intervention Type DRUG

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

Cystoscopy

Intervention Type PROCEDURE

Diagnostic cystoscopy performed during pelvic floor surgery

Interventions

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Cystoscopic Fluid containing Neosporin G. U. Irrigant

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

Intervention Type DRUG

Cystoscopy

Diagnostic cystoscopy performed during pelvic floor surgery

Intervention Type PROCEDURE

Cystoscopic Fluid/Placebo

Normal saline cystoscopic fluid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Mangel

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB15-00769

Identifier Type: -

Identifier Source: org_study_id