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

Phase 4

Not yet recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Bactrim or Macrobid; Drug: Placebo

• Registration Number: NCT06706362
• Lead Sponsor: Ohio State University

Brief 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).

Detailed Description

Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI).

Patients will be randomized and blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies.

Specific Aim 2: To assess if factors such as patient discharge with ISC/indwelling foley or number of Bulkamid injection sites is correlated to improvement in Stress urinary incontinence (SUI) at 6 weeks postoperatively and at one year postoperatively.

Patients will complete a brief survey preoperative, at 6 weeks postoperatively after their procedure, and at 1 year postoperatively after their procedure. The survey will consist of prior validated urogynecologic surveys including the Pelvic Floor Disability Index/Urinary Distress Inventory (PFDI/UDI- 6) and the MESA questionnaires as well as an extended VAS scale to evaluate global improvement.

Specific Aim 3: To discern if any patient characteristics are associated with higher patient satisfaction following the procedure.

Study Timeline

• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Study Start: 2025-04-15
• Primary Completion: 2027-04-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bactrim or Macrobid (single dose)	Bactrim or Macrobid	Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies
Placebo	Placebo	Identical appearing placebo for a single dose

Primary Outcome Measures

Name	Time	Method
Risk of post operative urinary tract infections (UTI)	6 weeks after the procedure	Intervention (pre-operative oral antibiotics) and placebo groups will be compared for the risk of post-operative UTIs following urethral bulking procedures performed in the operating room.; Patients who have symptoms, concerning for UTI during the immediate 6 week postoperative period will be asked to give a urine sample for culture. UTIs which are culture proven and symptomatic will be treated per individual provider preference. Positive urine cultures will be defined as cultures with greater than 50,000 CFU for voided specimens and greater than 5,000 CFU for catheter specimens. If a patient's urine culture is positive for mixed flora and cannot be speciated further by our microbiology laboratory, they will be asked to present for a straight catheter specimen in the office for definitive diagnosis; this is an established protocol which is already standard in our practice. All positive cultures during this time period will be recorded.

Secondary Outcome Measures

Name	Time	Method
Drug Use and Side Effects	6 weeks and 1 year after the procedure, up to 1 year	Assessing if factors such as patient discharge with Intermittent self-catheterization (ISC)/indwelling foley or number of Bulkamid injection sites is correlated to improvement in SUI at 6 weeks and 1 year postoperatively.
Effects on higher patient satisfaction	6 weeks and 1 year after the procedure, up to 1 year	If any patient characteristics are associated with higher patient satisfaction following the procedure.; Following the procedure, patients will be asked to complete a survey compromising of the Pelvic Floor Disability Index/Urinary Distress Inventory - Short Form (PFDI/UDI-6), the MESA questionnaire and an extended Visual Analogue Scale (VAS; scale of 0 or extremely unsatisfied to 100 or extremely satisfied). Patients will be given a paper copy of the survey at their 6 week post-operative appointment as well as an online link to complete the survey. This same survey will then be administered again approximately 1 year after the patient's procedure.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Columbus, Ohio, United States