Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06387329 · ClinicalTrials.gov registry record · Phase 4
Bladder Botox UTI Antibiotic Prophylaxis
A Phase 4 study of Overactive Bladder and Bladder Pain Syndrome, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06387329 is a Phase 4 study of Overactive Bladder and Bladder Pain Syndrome that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 100 participants, below the 209-participant average among 45 other Overactive Bladder trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06387329, a Phase 4 study of Overactive Bladder and Bladder Pain Syndrome, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Nitrofurantoin 100 MG
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06387329
The ClinicalTrials.gov registry entry for NCT06387329 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 45 other Overactive Bladder trials with a reported enrollment target (52% lower). The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Nitrofurantoin 100 MG is the first listed.
NCT06387329 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06387329 about?
NCT06387329 is a clinical study titled "Bladder Botox UTI Antibiotic Prophylaxis". 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 a...
What is the current status of trial NCT06387329?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-04-04. Estimated completion is 2025-06-30.
What conditions does trial NCT06387329 study?
This clinical trial studies the following conditions: Overactive Bladder, Bladder Pain Syndrome.
What interventions are being tested in trial NCT06387329?
The interventions under investigation include: Nitrofurantoin 100 MG (DRUG).
Who is sponsoring clinical trial NCT06387329?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06387329 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overactive Bladder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
RECRUITING · Phase 4
-
Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks
RECRUITING · Phase 4
-
TReating Incontinence for Underlying Mental and Physical Health
RECRUITING · Phase 4
-
Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder
COMPLETED · Phase 4
-
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
COMPLETED · Phase 4
-
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
COMPLETED · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.