The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

NCT ID: NCT06261736

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stress Urinary Incontinence Postoperative Urinary Tract Infection Urethral Bulking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prophylactic antibiotics

Intervention Type OTHER

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

No antibiotic group

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

Group Type OTHER

No antibiotics

Intervention Type OTHER

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

Interventions

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Prophylactic antibiotics

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

Intervention Type OTHER

No antibiotics

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Erika Wasenda

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika Wasenda, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

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Atlantic Health

Morristown, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tess Gao, MD

Role: CONTACT

973-971-7267

Facility Contacts

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Tess Gao, MD

Role: primary

9739717267

Other Identifiers

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2107044-1

Identifier Type: -

Identifier Source: org_study_id

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