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Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)

NCT06706362 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-10-08

No results posted yet for this study

Summary

The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).

Conditions

  • Stress Urinary Incontinence

Interventions

DRUG

Bactrim or Macrobid

Participants will be assigned to Bactrim or Macrobid depending on participants' allergies

DRUG

Placebo

Participants will be assigned to identical appearing placebo

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Susanne Taege, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-04-15
Completion
2027-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706362 on ClinicalTrials.gov