Stress Urinary IncontinencePhase 4NCT06706362
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
A Phase 4 study testing Bactrim or Macrobid in people with Stress Urinary Incontinence, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Bactrim or Macrobid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 15 Oct 2027
- Phase
- Phase 4
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Pelvic organ prolapse stage greater than 2
- Patients with immunosuppression due to underlying medical conditions
- Recent antibiotic treatment within one week of the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
Columbus, Ohio, 43210
Susanne Taege, MD, 614-293-4643, Susanne.Taege@osumc.edu
Shirley Dong, MD, 614-293-8045, Shirley.Dong@osumc.edu
About this study
Official title: Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid
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).
Read the detailed description
Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI).
Patients will be randomized and blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies.
Specific Aim 2: To assess if factors such as patient discharge with ISC/indwelling foley or number of Bulkamid injection sites is correlated to improvement in Stress urinary incontinence (SUI) at 6 weeks postoperatively and at one year postoperatively.
Patients will complete a brief survey preoperative, at 6 weeks postoperatively after their procedure, and at 1 year postoperatively after their procedure. The survey will consist of prior validated urogynecologic surveys including the Pelvic Floor Disability Index/Urinary Distress Inventory (PFDI/UDI- 6) and the MESA questionnaires as well as an extended VAS scale to evaluate global improvement.
Specific Aim 3: To discern if any patient characteristics are associated with higher patient satisfaction following the procedure.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Bactrim or Macrobid, Placebo
- Keywords
- Bulkamid, Urinary tract infections, Bactrim, Macrobid, Urethral bulking
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bactrim or MacrobidDrug
Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
PlaceboDrug
Participants will be assigned to identical appearing placebo
| Study group | Role | What they receive |
|---|---|---|
| Bactrim or Macrobid (single dose) | Active comparator | Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies Receives: Drug: Bactrim or Macrobid |
| Placebo | Placebo comparator | Identical appearing placebo for a single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after the procedure
Secondary outcomes (2)
Drug Use and Side Effects
Assessing if factors such as patient discharge with Intermittent self-catheterization (ISC)/indwelling foley or number of Bulkamid injection sites is correlated to improvement in SUI at 6 weeks and 1 year postoperatively.
Measured: 6 weeks and 1 year after the procedure, up to 1 year
Effects on higher patient satisfaction
If any patient characteristics are associated with higher patient satisfaction following the procedure.
Following the procedure, patients will be asked to complete a survey compromising of the Pelvic Floor Disability Index/Urinary Distress Inventory - Short Form (PFDI/UDI-6), the MESA questionnaire and an extended Visual Analogue Scale (VAS; scale of 0 or extremely unsatisfied to 100 or extremely satisfied). Patients will be given a paper copy of the survey at their 6 week post-operative appointment as well as an online link to complete the survey. This same survey will then be administered again approximately 1 year after the patient's procedure.
Measured: 6 weeks and 1 year after the procedure, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Sep 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a double-blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Taege, Ohio State University
- Investigators
- Susanne Taege, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706362
- Sponsor's protocol ID
- 2024H0366
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No