NCT06387329 Bladder Botox UTI Antibiotic Prophylaxis
| NCT ID | NCT06387329 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Walter Reed National Military Medical Center |
| Condition | Overactive Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2025-06-30 |
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 100 participants in total. It began in 2024-04-04 with a primary completion date of 2025-06-30.
⚠ 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
Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance. The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure. The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure. A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection.
Eligibility Criteria
Inclusion Criteria: * All patients 18 years or older being seen at the WRNMMC Urogynecology clinic * Diagnosis of OAB or IC/BPS * Planning to undergo intradetrusor onabotulinumtoxinA injection for treatment of their OAB or IC/BPS * Ability to follow instructions and complete follow up Exclusion Criteria: * Contraindication to nitrofurantoin (allergy, CrCl \<30mL/minute) * If performed in the operating room, the patient cannot undergo a concurrent procedure that would increase the risk of UTI or require an alternate antibiotic regimen (such as hysterectomy, prolapse repair, or anti-incontinence procedure) * Active UTI at the time of procedure * Neurogenic bladder * Recurrent UTI (3 in 12 month period or 2 in 6 months) * Post void residual bladder volume ≥150mL * Patient is already taking antibiotics at the time of the procedure * Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)
Contact & Investigator
Jordan Gisseman, MD
PRINCIPAL INVESTIGATOR
Walter Reed National Military Medical Center
Frequently Asked Questions
Who can join the NCT06387329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Overactive Bladder. 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 NCT06387329 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 NCT06387329 currently recruiting?
Yes, NCT06387329 is actively recruiting participants. Contact the research team at jordan.gisseman.mil@health.mil for enrollment information.
Where is the NCT06387329 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06387329 clinical trial?
NCT06387329 is sponsored by Walter Reed National Military Medical Center. The principal investigator is Jordan Gisseman, MD at Walter Reed National Military Medical Center. The trial plans to enroll 100 participants.