The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Postoperative Urinary Tract Infection; Urethral Bulking
• Intervention / Treatment: Other: Prophylactic antibiotics; Other: No antibiotics

Detailed Description

Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tess Gao, MD; Phone Number: 973-971-7267; Email: tess.gao@atlantichealth.org

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health
      • Contact: Tess Gao, MD; Phone Number: 9739717267; Email: tess.gao@atlantichealth.org
      • Contact: Erika Wasenda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled to undergo a urethral bulking procedure
• Age 18 ≥ over

Exclusion Criteria:

• History of recurrent urinary tract infections
• Known history of urinary retention
• Allergies or contraindications to multiple antibiotics
• Inability to tolerate oral antibiotics
• Concomitant surgical procedures at the time of urethral bulking
• Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic Group; Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.	Other: Prophylactic antibiotics; These participants will be given a single dose of an oral antibiotic prior to the procedure.
Other: No antibiotic group; Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.	Other: No antibiotics; These participants will not be given an antibiotic prior to the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of urinary tract infection (UTI)	The rate of UTI based on symptoms and a positive urine culture	Within 4 weeks after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative urinary retention	The rate of postoperative urinary retention	Within 4 weeks after the procedure
Rates of other postoperative complications	The rate of other complications (bleeding, discomfort, etc)	Within 4 weeks after the procedure

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Investigators: Principal Investigator: Erika Wasenda, MD, Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Infections; Urinary Incontinence; Urinary Incontinence, Stress; Urinary Tract Infections; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 2107044-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No