The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

NCT06261736 | Recruiting

• 1 other identifier: 2107044-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Urinary Incontinence; Postoperative Urinary Tract Infection; Urethral Bulking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of postoperative urinary retention

  Within 4 weeks after the procedure

• Rates of other postoperative complications

  Within 4 weeks after the procedure

Study Arms (2)

Antibiotic Group

EXPERIMENTAL

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

No antibiotic group

OTHER

Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.

Other: No antibiotics

Interventions

Prophylactic antibiotics OTHER

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

Antibiotic Group

No antibiotics OTHER

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

No antibiotic group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Atlantic Health

Morristown, New Jersey, 07960, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika Wasenda, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tess Gao, MD

CONTACT

973-971-7267; tess.gao@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: October 24, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)