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OpenTrials
Not yet recruiting

NCT Number: NCT07795255

Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

For patients undergoing cystoscopy who choose or do not choose to watch the procedure on a screen: Does long vs. short dwell-time lidocaine, and music vs. no music, more effectively reduce pain and anxiety and improve satisfaction and adherence to clinician recommendations for follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.

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)

Treatment and study plan

Headphones

Device

Music playlists include Jazz, New Age, and Classical. Participants randomized to listening to music will chose to listen to one of the three playlists provided. Headphones with a single-use cover will be placed over the ears prior to the administration of numbing medication, and prior to the start of the cystoscopy procedure.

Other names: Music

Dwell time 5-10 minutes

Drug

Numbing medication dwell time, 5-10 minutes.

Other names: Short Lidocaine

Dwell Time more than 10 minutes

Drug

Numbing medication dwell time, >10 minutes.

Other names: Long Lidocaine

Primary outcomes

  1. Pain level

    Time frame: Assessed immediately after each cystoscopy procedure.

    Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain

Secondary outcomes

  1. Pain intensity

    Time frame: Assessed immediately after each cystoscopy procedure.

    PROMIS Pain Intensity Scale v2.0 - Pain Intensity 3a. Scale is 1-5; higher number indicates higher level of pain.

  2. Level of emotional distress and anxiety

    Time frame: Assessed immediately after each cystoscopy procedure.

    PROMIS Emotional Distress-Anxiety Short Form 4a. Scale is 1-5; higher number indicates higher level of distress-anxiety.

  3. Patient Satisfaction

    Time frame: Assessed immediately after each cystoscopy procedure;

    Client Satisfaction Questionnaire (CSQ-3). Scale is 1-4; higher number indicates higher level of satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Florian R Schroeck, MD, MS

CONTACT

[email protected]

802-295-9363 ext. 6593

Laura L Jensen, MPH

CONTACT

[email protected]

802-295-9363 ext. 6953

Sponsors and collaborators

Lead sponsor

Florian Schroeck

Fed

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 31, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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