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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06706362
Phase
PHASE4
Status
Recruiting
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Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Bactrim or Macrobid — DRUG
    Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
  • Placebo — DRUG
    Participants will be assigned to identical appearing placebo

Study Details

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).

Key Dates

Start date
Sep 15, 2025
Status verified
Oct 2025
Primary completion
Apr 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bactrim or Macrobid (single dose)
    Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies
  • Placebo Comparator: Placebo
    Identical appearing placebo for a single dose

Primary Outcome Measure

Risk of post operative urinary tract infections (UTI) [ Time Frame: 6 weeks after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive SurgeryColumbusOhio43210
Susanne Taege, MD
[email protected]
614-293-4643
Shirley Dong, MD
[email protected]
614-293-8045
Susanne Taege, MD (PRINCIPAL_INVESTIGATOR)
Shirley Dong, MD (SUB_INVESTIGATOR)

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By research site
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery· Columbus, OH

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