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Antibiotic

Single dose arm for Overactive Bladder

Phase 4

Recruiting

Led By Jordan Gisseman, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of OAB or IC/BPS

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days after intradetrusor injection of onabotulinumtoxina

Awards & highlights

Study Summary

"This trial aims to determine the best way to prevent urinary tract infections (UTIs) in female patients with overactive bladder or bladder pain syndrome who are treated with onabotulinumtoxinA

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include issues related to antibiotic use such as stomach upset, diarrhea, and in some cases, allergic reactions. Long-term use can lead to increased resistance to antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with overactive bladder or interstitial cystitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days after intradetrusor injection of onabotulinumtoxina

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days after intradetrusor injection of onabotulinumtoxina

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days after intradetrusor injection of onabotulinumtoxina for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Urinary tract infection

Secondary outcome measures

Adverse effects

Urinary retention

Urinary tract infection symptoms

Side effects data

From 2019 Phase 4 trial • 164 Patients • NCT03287089

Medication Intolerance

100%

80%

60%

40%

20%

Study treatment Arm

Nitrofurantoin

Placebo

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitrofurantoin 100 MG

2021

Completed Phase 4

~230

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor

138 Previous Clinical Trials

33,438 Total Patients Enrolled

Jordan Gisseman, MDPrincipal InvestigatorWalter Reed National Military Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for potential participants to enroll in this trial?

"As per clinicaltrials.gov, this research is actively seeking participants. It was first listed on April 4th, 2024 and most recently revised on April 24th of the same year."

Answered by AI

What is the upper limit on the number of participants involved in this medical study?

"Affirmative. The information available on clinicaltrials.gov confirms the ongoing recruitment for participants in this medical trial. Originally listed on April 4th, 2024, and last revised on April 24th, 2024, the study aims to enroll a total of 100 subjects at one designated site."

Answered by AI

Has the single-dose treatment been officially authorized by the FDA?

"The safety rating for the single-dose arm has been assessed as 3 by our team at Power, owing to this being a Phase 4 trial denoting official approval of the treatment."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Efficacy and Safety of Onabotulinumtoxina for Idiopathic Overactive Bladder: A Double-blind, Placebo Controlled, Randomized, Dose Ranging Trial

Dmochowski, Roger, Christopher Chapple, Victor W. Nitti, Michael Chancellor, Karel Everaert, Catherine Thompson, Grace Daniell, Jihao Zhou, and Cornelia Haag-Molkenteller. 2010. “Efficacy and Safety of Onabotulinumtoxina for Idiopathic Overactive Bladder: A Double-blind, Placebo Controlled, Randomized, Dose Ranging Trial”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2010.08.021.

European UrologyJournal

Onabotulinumtoxina 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised, Double-blind, Placebo-controlled Trial

Chapple, Christopher, Karl-Dietrich Sievert, Scott MacDiarmid, Vik Khullar, Piotr Radziszewski, Christopher Nardo, Catherine Thompson, Jihao Zhou, and Cornelia Haag-Molkenteller. 2013. “Onabotulinumtoxina 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised, Double-blind, Placebo-controlled Trial”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2013.04.001.

BJU InternationalJournal

Patient-reported Reasons for Discontinuing Overactive Bladder Medication

Benner, Joshua S., Michael B. Nichol, Eric S. Rovner, Zhanna Jumadilova, Jose Alvir, Mohamed Hussein, Kristina Fanning, Jeffrey N. Trocio, and Linda Brubaker. 2010. “Patient-reported Reasons for Discontinuing Overactive Bladder Medication”. BJU International. Wiley. doi:10.1111/j.1464-410x.2009.09036.x.

JAMA Internal MedicineJournal