Using Botox to treat overactive bladder while preventing urinary tract infections
Urinary Tract Infection Prophylaxis In Intradetrusor OnabotulinumtoxinA Procedures: A Randomized Controlled Trial
This study is testing if Botox injections for overactive bladder can be safely combined with a specific antibiotic to help prevent urinary tract infections in women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06387329 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of intradetrusor onabotulinumtoxinA injections for treating overactive bladder (OAB) and bladder pain syndrome (IC/BPS) in female patients. The study aims to determine the optimal antibiotic prophylaxis regimen, specifically nitrofurantoin, to prevent urinary tract infections (UTIs) that may occur after the Botox treatment. By evaluating the timing, duration, and type of antibiotic, the trial seeks to minimize antibiotic use while effectively preventing UTIs, addressing a significant gap in current treatment protocols. The study population includes women aged 18 and older who are planning to undergo Botox injections for their condition.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older diagnosed with overactive bladder or bladder pain syndrome who are planning to receive Botox injections.
Not a fit: Patients with contraindications to nitrofurantoin, active urinary tract infections, or those with recurrent UTIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer approach to managing urinary tract infections in patients receiving Botox for overactive bladder.
How similar studies have performed: While there have been retrospective studies on antibiotic prophylaxis for this population, this prospective study aims to fill a gap in the literature and is considered novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jordan Gisseman, MD — Walter Reed National Military Medical Center
- Study coordinator: Jordan Gisseman, MD
- Email: jordan.gisseman.mil@health.mil
- Phone: 301-400-2468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.