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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: Placebo; Drug: Bactrim or Macrobid

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Susanne Taege, MD; Phone Number: 614-293-4643; Email: Susanne.Taege@osumc.edu
• Study Contact Backup: Name: Shirley Dong, MD; Phone Number: 614-293-8045; Email: Shirley.Dong@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
      • Contact: Susanne Taege, MD; Phone Number: 614-293-4643; Email: Susanne.Taege@osumc.edu
      • Contact: Shirley Dong, MD; Phone Number: 614-293-8045; Email: Shirley.Dong@osumc.edu
      • Principal Investigator: Susanne Taege, MD
      • Sub-Investigator: Shirley Dong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
• Negative testing for UTI in pre-operative work-up (including either negative urine culture or urine dip negative for infection).
• Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST).
• Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)

Exclusion Criteria

• Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease
• Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly
• Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months
• Patients currently taking daily antibiotic prophylaxis for any reason
• Non-English speaking patients
• Pregnant patients
• Pelvic organ prolapse stage greater than 2
• Patients with immunosuppression due to underlying medical conditions
• Recent antibiotic treatment within one week of the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bactrim or Macrobid (single dose); Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies	Drug: Bactrim or Macrobid; Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
Placebo Comparator: Placebo; Identical appearing placebo for a single dose	Drug: Placebo; Participants will be assigned to identical appearing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of post operative urinary tract infections (UTI)	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.	6 weeks after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Use and Side Effects	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.	6 weeks and 1 year after the procedure, up to 1 year
Effects on higher patient satisfaction	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.	6 weeks and 1 year after the procedure, up to 1 year

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Susanne Taege, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Bulkamid; Urinary tract infections; Bactrim; Macrobid; Urethral bulking
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Infections; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Urinary Tract Infections; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Aniline Compounds; Amines; Pyrimidines; Benzene Derivatives; Drug Combinations; Nitro Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Sulfones; Trimethoprim; Furans; Nitrofurans; Trimethoprim, Sulfamethoxazole Drug Combination; Nitrofurantoin
• Other Study ID Numbers: 2024H0366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No