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NCT06261736 Clinical Trial

The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Stress Urinary Incontinence Clinical Trial

Official title:
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06261736
Other study ID # 2107044-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2023
Est. completion date May 2025

Study information
Verified date February 2024
Source Atlantic Health System
Contact Tess Gao, MD
Phone 973-971-7267
Email tess.gao@atlantichealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Prophylactic antibiotics
These participants will be given a single dose of an oral antibiotic prior to the procedure.
• No antibiotics
These participants will not be given an antibiotic prior to the procedure.

Locations
Country Name City State
United States Atlantic Health Morristown New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Rate of postoperative urinary retention The rate of postoperative urinary retention Within 4 weeks after the procedure
Secondary Rates of other postoperative complications The rate of other complications (bleeding, discomfort, etc) Within 4 weeks after the procedure
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