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Interventions for Cystoscopy Discomfort in Bladder Cancer

Not yet recruiting at 4 trial locations
FR
LL
Overseen ByLaura L Jensen, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Florian Schroeck
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to learn methods doctors can use to help improve the cystoscopy experience. Specifically, this study will determine if listening to music, and the amount of time Lidocaine (a numbing medication) is allowed to rest in your urethra before beginning the cystoscopy procedure, will improve the cystoscopy experience.

Who Is on the Research Team?

FR

Florian R Schroeck, MD, MS

Principal Investigator

White River Junction Veterans Healthcare System

Are You a Good Fit for This Trial?

This trial is for people who need a cystoscopy, often due to bladder cancer or blood in the urine. Participants must be able to undergo this procedure and not have conditions that would prevent safe participation.

Inclusion Criteria

I am having a cystoscopy in my doctor's office for my bladder condition.

Exclusion Criteria

Allergy to or intolerance of lidocaine.
Intolerance of all offered music genre playlists (Jazz, Classical, New Age), such that no acceptable music option exists.
Known pregnancy or lactation (routine pregnancy testing is not required)

What Are the Treatments Tested in This Trial?

Interventions

  • Headphones
  • Lidocaine

Trial Overview

The study tests if listening to music with headphones and varying how long Lidocaine (a numbing gel) stays in place before cystoscopy can make the procedure more comfortable. Different dwell times of Lidocaine are compared.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: No music and long dwell timeExperimental Treatment1 Intervention
Group II: Music and short dwell timeExperimental Treatment2 Interventions
Group III: Music and long dwell timeExperimental Treatment2 Interventions
Group IV: No music and short dwell timeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florian Schroeck

Lead Sponsor

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