Recruiting

Prophylactic Antibiotics

Sponsor:

Atlantic Health System

Code:

NCT06261736

Conditions

Stress Urinary Incontinence

Postoperative Urinary Tract Infection

Urethral Bulking

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic antibiotics

No antibiotics

Study Details

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

Study ID

NCT06261736

Start date

Oct 24, 2023

Status verified date

Apr, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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: No antibiotic group

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

Interventions

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.

Primary outcome measure

  • Rate of urinary tract infection (UTI) [ Time Frame: Within 4 weeks after the procedure ]

Central Contacts and Locations

Central contacts

Tess Gao, MD

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

Locations

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Tess Gao, MD

9739717267tess.gao@atlantichealth.org

Principal Investigator:

Erika Wasenda, MD

More Information

Sponsor

Atlantic Health System

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2025-04-08.