Antibiotic Prophylaxis for UTIs in Overactive Bladder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Walter Reed National Military Medical Center
Must be taking:Nitrofurantoin
Must not be taking: Antibiotics
Disqualifiers: Neurogenic bladder, Recurrent UTI, others
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking antibiotics at the time of the procedure.
What data supports the effectiveness of the drug Nitrofurantoin for preventing urinary tract infections (UTIs) in patients with overactive bladder?
Research shows that Nitrofurantoin is effective in preventing urinary tract infections (UTIs) after certain surgeries, like those for pelvic organ prolapse, and is commonly recommended for treating UTIs. However, its effectiveness may be reduced in patients with kidney problems.
12345Is nitrofurantoin safe for humans?
Nitrofurantoin has been used for over 60 years to prevent urinary tract infections and is generally considered safe, but it may cause serious side effects in people with kidney problems.
12678How is the drug Nitrofurantoin unique for treating overactive bladder with UTIs?
Nitrofurantoin is unique for treating overactive bladder with UTIs because it is primarily an antibiotic used to prevent urinary tract infections, rather than directly addressing bladder muscle activity like other treatments for overactive bladder.
910111213Eligibility Criteria
This trial is for female patients aged 18 or older who visit the urogynecology and urology clinics at Walter Reed National Military Medical Center, have been diagnosed with overactive bladder (OAB) or interstitial cystitis/bladder pain syndrome (IC/BPS), and opt for Botox injections into the bladder. Participants must not currently have a UTI.Inclusion Criteria
I have been diagnosed with overactive bladder or interstitial cystitis.
Exclusion Criteria
I am not allergic to, pregnant, or have had over 400 units of Botox in the last 3 months.
I am allergic to nitrofurantoin or my kidney function is poor.
I currently have a urinary tract infection.
I have had 3 UTIs in the last year or 2 in the last 6 months.
I am currently on antibiotics.
I have a condition where my bladder doesn't function properly due to nerve damage.
I am not having any additional surgeries that raise UTI risk or need different antibiotics.
Participant Groups
The study aims to find out if taking one dose of Nitrofurantoin 100mg at the time of Botox injection into the bladder is as effective in preventing UTIs as taking it twice daily for three days starting from the procedure day. It's a non-blinded randomized controlled trial comparing these two antibiotic regimens.
2Treatment groups
Experimental Treatment
Active Control
Group I: Single dose armExperimental Treatment1 Intervention
Subjects will be given a single dose of 100mg nitrofurantoin by mouth at the time of intradetrusor injection of 100u onabotulinumtoxinA
Group II: 3 day armActive Control1 Intervention
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
Nitrofurantoin is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Macrobid for:
- Urinary tract infections
- Prostatitis
🇨🇦 Approved in Canada as Macrodantin for:
- Urinary tract infections
- Prostatitis
🇪🇺 Approved in European Union as Furadantin for:
- Urinary tract infections
- Prostatitis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Walter Reed National Military Medical CenterBethesda, MD
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Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
References
Choice of Empirical Antibiotic Therapy and Adverse Outcomes in Older Adults With Suspected Urinary Tract Infection: Cohort Study. [2022]Nitrofurantoin is widely recommended for empirical treatment of urinary tract infection (UTI), but primary care clinicians may prescribe alternative antibiotics to improve prognosis in older, sicker patients. We assessed whether prescribing alternative antibiotics was associated with reduced risk of adverse outcomes in older patients.
Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care. [2021]To determine whether treatment with nitrofurantoin in women with urinary tract infection (UTI) and renal impairment in primary care is associated with a higher risk of ineffectiveness and/or serious adverse events than in women without renal impairment.
Randomized trial of antibiotic prophylaxis for combined urodynamics and cystourethroscopy. [2022]To determine the efficacy of prophylactic nitrofurantoin in preventing bacteriuria after urodynamics and cystourethroscopy.
Efficacy of vaccination with StroVac for recurrent urinary tract infections in women: a comparative single-centre study. [2022]To assess the efficacy of prophylaxis for urinary tract infections (UTI) in a two-year follow-up in women with StroVac compared to a therapy with Nitrofurantoin over three months.
A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic catheterization. [2022]The purpose of this study was to determine if antibiotic prophylaxis with nitrofurantoin monohydrate macrocrystals (study drug) after pelvic organ prolapse and/or urinary incontinence surgery with suprapubic catheterization (SPC) decreases urinary tract infection (uti) compared with placebo in a randomized, double-blind, multicenter trial.
Nitrofurantoin's efficacy and safety as prophylaxis for urinary tract infections: a systematic review of the literature and meta-analysis of controlled trials. [2022]Nitrofurantoin has been used for the prevention of urinary tract infection (UTI) for over 60 years. We conducted a systematic review and meta-analysis to assess its efficacy and safety in the prophylaxis of UTI.
Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency. [2022]The emergence of antimicrobial resistance in uropathogens has generated interest in the use of nitrofurantoin in controversial populations, such as in males and those with renal dysfunction. The purpose of this study was to compare the efficacy and safety of nitrofurantoin for the treatment of cystitis in males and females with variable degrees of renal dysfunction.
Effectiveness and safety of nitrofurantoin in outpatient male veterans. [2020]The aim of the study was to assess both the safety and the effectiveness of nitrofurantoin in male veterans treated for urinary tract infections (UTIs) with varying degrees of renal impairment in the outpatient setting. Nitrofurantoin is an important oral option for treating UTIs given increasing resistance to commonly used agents. Nitrofurantoin is currently contraindicated in patients with a creatinine clearance (CrCl) of
Effect of Imidafenacin before Sleeping on Nocturia. [2015]Clinical efficacy, influence on quality of life (QOL), and safety of imidafenacin before sleeping were assessed in patients with overactive bladder (OAB) who suffered from nocturia.
Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open-label, controlled trial (DIrecT Study). [2019]To evaluate the efficacy and safety of a combination therapy with dutasteride and imidafenacin in patients with benign prostatic hyperplasia and persistent overactive bladder symptoms.
A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan. [2021]This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration.
A randomized, double-blind, placebo-controlled phase II dose-finding study of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladder. [2012]To evaluate the efficacy, safety/tolerability, and dose-response relationship of imidafenacin in Japanese patients with overactive bladder.
Effect of imidafenacin on nocturia and sleep disorder in patients with overactive bladder. [2015]To evaluate the efficacy of imidafenacin on nocturia and sleep disorder in patients with overactive bladder (OAB).