Urinary Tract InfectionsPhase 4NCT07501065
Prophylactic Antibiotics for Outpatient Urethral Bulking
A Phase 4 study testing Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) in people with Urinary Tract Infections and Stress Urinary Incontinence, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence
- What is being tested?
- Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years of age.
- Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
- Negative testing for UTI in pre-procedural work-up, including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and/or pyuria with >1+ leukocyte esterase on dipstick or >5 WBC/HPF).
- Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure
- Fluent in English or Spanish
- Able and willing to provide informed consent
Who cannot join
- Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR <30)
- Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly that also involve insertion [KB2.1]of a foreign object
- 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
- Patients with immunosuppression due to underlying medical conditions
- Patients who are pregnant
- Recent antibiotic treatment within one week of the procedure
- Unable or unwilling to provide informed consent or complete study procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Desai Sethi Urology Institute
Miami, Florida, 33136
Elena Cortizas, MS, (305) 243-3593, ecortizas@med.miami.edu
Katherine Amin, MD
- Recruiting
University of Miami Hospitals and Clinics
Miami, Florida, 33136
Elena Cortizas, MS, 305-243-3593
Katherine Amin, MD
About this study
Official title: Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
- Being tested
- Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
- Medical subject headings
- Urinary Tract Infections, Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)Drug
Also called Sulfamethoxazole, Trimethoprim, Nitrofurantoin, Cephalexin
Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Antibiotic Group | Experimental | Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic-based urethral bulking procedure. Receives: Drug: Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) |
| No Prophylactic Antibiotic Group | No intervention | Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start19 Aug 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Amin, University of Miami
- Investigators
- Katherine Amin, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501065
- Sponsor's protocol ID
- 20260233
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
- ClinicalTrials.gov ID
- NCT07501065
- Acronym / sponsor ID
- 20260233
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Antibiotic Group | Experimental | Drug: Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic-based urethral bulking procedure. |
| No Prophylactic Antibiotic Group | No intervention | –Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women ≥ 18 years of age.
- Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
- Negative testing for UTI in pre-procedural work-up, including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and/or pyuria with >1+ leukocyte esterase on dipstick or >5 WBC/HPF).
- Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure
- Fluent in English or Spanish
Key exclusion criteria (8 listed)
- Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR <30)
- Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly that also involve insertion [KB2.1]of a foreign object
- 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
- Patients with immunosuppression due to underlying medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)Also: Sulfamethoxazole, Trimethoprim, Nitrofurantoin, CephalexinParticipants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure. | Drug | Prophylactic Antibiotic Group |
Primary outcome
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
Time frame: 6 Weeks
The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Amin, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) in people with Urinary Tract Infections and Stress Urinary Incontinence, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Amin, MD ((305) 243-6590, katherine.amin@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.