NCT06706362 Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
| NCT ID | NCT06706362 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 138 participants in total. It began in 2025-09-15 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Susanne Taege, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06706362 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06706362 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06706362 currently recruiting?
Yes, NCT06706362 is actively recruiting participants. Contact the research team at Susanne.Taege@osumc.edu for enrollment information.
Where is the NCT06706362 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06706362 clinical trial?
NCT06706362 is sponsored by Ohio State University. The principal investigator is Susanne Taege, MD at Ohio State University. The trial plans to enroll 138 participants.