Bladder Botox UTI Antibiotic Prophylaxis

NCT06387329 | Recruiting Phase 4 FDA Drug

• 1 other identifier: WRNMMC-2023-0438
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Bladder Pain Syndrome

Keywords

Intradetrusor Onabotulinumtoxin A; Urinary tract infection; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Urinary tract infection

  To evaluate for non-inferiority in the number of post-procedure urinary tract infections proven by a urine culture

  Within 30 days after intradetrusor injection of onabotulinumtoxinA

Secondary Outcomes (3)

• Urinary tract infection symptoms

  Within 30 days after intradetrusor injection of onabotulinumtoxinA

• Urinary retention

  Within 30 days after intradetrusor injection of onabotulinumtoxinA

• Adverse effects

  Within 30 days after intradetrusor injection of onabotulinumtoxinA

Study Arms (2)

3 day arm

ACTIVE COMPARATOR

Subjects will be given a 3 day twice daily course of 100mg nitrofurantoin by mouth starting at the time of intradetrusor injection of 100u onabotulinumtoxinA

Drug: Nitrofurantoin 100 MG

Single dose arm

EXPERIMENTAL

Subjects will be given a single dose of 100mg nitrofurantoin by mouth at the time of intradetrusor injection of 100u onabotulinumtoxinA

Drug: Nitrofurantoin 100 MG

Interventions

Nitrofurantoin 100 MG DRUG

No additional information

Also known as: Macrobid

3 day arm; Single dose arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20899, United States

RECRUITING

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Cystitis, Interstitial; Urinary Tract Infections

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cystitis; Infections

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jordan Gisseman, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Gisseman, MD

CONTACT

301-400-2468; jordan.gisseman.mil@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Nonblinded, randomized, noninferiority trial of single dose nitrofurantoin vs 3 day twice daily course of nitrofurantoin for prevention of post-procedure urinary tract infections after intradetrusor onabotulinumtoxinA injections for OAB and IC/BPS.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 29, 2024
• Study Start: April 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)