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Analgesic

Analgesia for Overactive Bladder

Phase 4

Waitlist Available

Led By Melissa Laudano, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Planning to undergo surgical management of idiopathic overactive bladder with intradetrusor onabotulinumtoxinA injection at Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department

Be older than 18 years old

Must not have

Non-English or non-Spanish speaking.

Current Urinary Tract Infection (UTI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of the procedure

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study whether a medication called phenazopyridine (Pyridium) is as effective as lidocaine in reducing pain during botox injections for overactive bladder at Montefiore

Who is the study for?

This trial is for patients at Montefiore Medical Center with overactive bladder conditions who are undergoing botox injections for treatment. Participants should not have any health issues that would interfere with the study or medication use.

What is being tested?

The study compares oral phenazopyridine (Pyridium) to intravesical lidocaine, which is a liquid administered into the bladder, to see if Pyridium can manage pain as effectively during bladder botox injections.

What are the potential side effects?

Possible side effects of phenazopyridine may include headache, dizziness, stomach cramps and orange-colored urine. Lidocaine might cause symptoms like local irritation and in rare cases systemic toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I am planning to have Botox injections for overactive bladder at Montefiore.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English or Spanish.

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I currently have a urinary tract infection.

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I have been diagnosed with a neurogenic bladder.

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I have undergone radiation therapy in the pelvic area.

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I have significant memory or thinking problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bladder Pain

Secondary study objectives

Bladder visualization

Patient satisfaction

Postoperative Analgesia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Intravesical lidocaineActive Control1 Intervention

Patients randomized to the intravesical lidocaine arm will be administered 50 cubic centimeters (cc) of 1% lidocaine with 50cc sodium bicarbonate within the bladder immediately prior to the procedure.

Group II: Oral phenazopyridineActive Control1 Intervention

Patients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure.

0 / 6Eligibility criteria met