Recruiting

Bulkamid

Sponsor:

Ohio State University

Code:

NCT06706362

Conditions

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Bactrim or Macrobid

Placebo

Study Details

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

Study ID

NCT06706362

Start date

Sep 15, 2025

Status verified date

Oct, 2025

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Bactrim or Macrobid

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

Placebo

Participants will be assigned to identical appearing placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Susanne Taege, MD

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

Shirley Dong, MD

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

Locations

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Susanne Taege, MD

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

Shirley Dong, MD

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

Principal Investigator:

Susanne Taege, MD

More Information

Sponsor

Ohio State University

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-10-08.