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New treatment option for Stress Urinary Incontinence
Official title Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
ClinicalTrials.gov ID: NCT06706362
What this study is testing
What is Bactrim or Macrobid?
Bactrim or Macrobid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for stress urinary incontinence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral...
- 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 likely can't join 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
See the full eligibility 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.