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

NCT06706362 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024H0366
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Urinary Incontinence

Keywords

Bulkamid; Urinary tract infections; Bactrim; Macrobid; Urethral bulking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Drug Use and Side Effects

  6 weeks and 1 year after the procedure, up to 1 year

• Effects on higher patient satisfaction

  6 weeks and 1 year after the procedure, up to 1 year

Study Arms (2)

Bactrim or Macrobid (single dose)

ACTIVE COMPARATOR

Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies

Drug: Bactrim or Macrobid

Placebo

PLACEBO COMPARATOR

Identical appearing placebo for a single dose

Drug: Placebo

Interventions

Bactrim or Macrobid DRUG

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

Bactrim or Macrobid (single dose)

Placebo DRUG

Participants will be assigned to identical appearing placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Nitrofurantoin

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Nitrofurans; Nitro Compounds; Furans

Study Officials

• Susanne Taege, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Taege, MD

CONTACT

614-293-4643; Susanne.Taege@osumc.edu

Shirley Dong, MD

CONTACT

614-293-8045; Shirley.Dong@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: a double-blinded randomized controlled trial

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 26, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)