Using Botox to treat overactive bladder while preventing urinary tract infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aerobic Exercise and Massage for Painful Bladder Syndrome in Women

  This study tests whether adding aerobic exercise and connective tissue massage to patient education helps reduce bladder pain and improve symptoms for women with bladder pain syndrome.

  Recruiting Hacettepe University · Ankara, Ankara · NCT07839689

• Flyte device to help urinary incontinence after pelvic radiation for endometrial or cervical cancer

  This study tests whether a home-use Flyte device, used during guided pelvic floor exercises, can improve urinary incontinence in women who had pelvic radiation for endometrial or cervical cancer.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07662824

• Self-Start Macrobid for post-Botox lower urinary symptoms

  This study tests whether giving a standing prescription for Macrobid after Botox treatment reduces urgent calls, messages, and visits for urinary symptoms compared with usual triage care.

  Recruiting Early Phase 1 The Cleveland Clinic · Cleveland, Ohio · NCT07648290

• Neovasculgen for interstitial cystitis with Hunner's lesions

  This study will test whether Neovasculgen can reduce bladder scarring and prevent bladder shrinkage in women with interstitial cystitis and Hunner's lesions.

  Recruiting Phase 2/3 JSC NextGen · Moscow · NCT07459790

• ZIDA Control Sock added to medication for overactive bladder with leakage

  This trial will try using the ZIDA Control Sock once a week at home for 12 weeks to see if adding it to your current medication reduces urgency urinary incontinence.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07432659

• Vaginal radiofrequency treatment targeting bladder nerves for overactive bladder in women

  This trial will test whether a single vaginal radiofrequency treatment with the MORPHEUSV device can reduce urgency-related urine leaks in adult women with overactive bladder.

  Recruiting at 5 sites InMode MD Ltd. · Palo Alto, California and 8 other locations · NCT07209397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.