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NCT Number: NCT06261736

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Postoperative Urinary Tract Infection Signs and Symptoms Urethral Bulking Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location status: Recruiting

Location contact

Erika Wasenda, MD

PRINCIPAL_INVESTIGATOR

Tess Gao, MD

CONTACT

[email protected]

9739717267

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Prophylactic antibiotics

Other

These participants will be given a single dose of an oral antibiotic prior to the procedure.

No antibiotics

Other

These participants will not be given an antibiotic prior to the procedure.

Primary outcomes

  1. Rate of urinary tract infection (UTI)

    Time frame: Within 4 weeks after the procedure

    The rate of UTI based on symptoms and a positive urine culture

Secondary outcomes

  1. Rate of postoperative urinary retention

    Time frame: Within 4 weeks after the procedure

    The rate of postoperative urinary retention

  2. Rates of other postoperative complications

    Time frame: Within 4 weeks after the procedure

    The rate of other complications (bleeding, discomfort, etc)

Study contacts

Contact information is provided by the study sponsor or research team.

Tess Gao, MD

CONTACT

[email protected]

973-971-7267

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2024
Registry last updated
Apr 8, 2025

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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