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Not yet recruitingNCT07795255Updated Sep 1, 2026

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

A Phase 3 interventional study of Headphones and Dwell time 5-10 minutes in Bladder (Urothelial, Transitional Cell) Cancer and Hematuria, sponsored by Florian Schroeck. Not yet recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Florian Schroeck · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
1,740
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Bladder (Urothelial, Transitional Cell) Cancer
  • Hematuria

Keywords

  • Cystoscopy
  • Bladder Cancer
  • Hematuria
  • Microhematuria
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
04

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
1,740 participants (estimated)

Study arms

  • Experimental
    Music and short dwell time

    Listening to music and 5-10 minute numbing medication dwell time

    Device: Headphones · Drug: Dwell time 5-10 minutes

  • Active comparator
    No music and short dwell time

    5 - 10 minute numbing medication dwell time

    Drug: Dwell time 5-10 minutes

  • Experimental
    Music and long dwell time

    Listening to music and \>10 minute numbing medication dwell time

    Device: Headphones · Drug: Dwell Time more than 10 minutes

  • Experimental
    No music and long dwell time

    \>10 minute numbing medication dwell time

    Drug: Dwell Time more than 10 minutes

Interventions

  • DeviceHeadphones

    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.

    Also known as: Music

  • DrugDwell time 5-10 minutes

    Numbing medication dwell time, 5-10 minutes.

    Also known as: Short Lidocaine

  • DrugDwell Time more than 10 minutes

    Numbing medication dwell time, \>10 minutes.

    Also known as: Long Lidocaine

05

What researchers measure

Primary outcomes

  1. Pain level

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

    Time frame: Assessed immediately after each cystoscopy procedure.

Secondary outcomes

  1. Pain intensity

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

    Time frame: Assessed immediately after each cystoscopy procedure.

  2. Level of emotional distress and anxiety

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

    Time frame: Assessed immediately after each cystoscopy procedure.

  3. Patient Satisfaction

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

    Time frame: Assessed immediately after each cystoscopy procedure;

06

Study locations

5 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    • Kaelin Hodges · Contact · kaelins@uab.edu
    • Charles Peyton, MD · Principal investigator
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • Novant Health New Hanover Regional Medical Center
    Wilmington, North Carolina 28401, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • White River Junction Veterans Healthcare System
    White River Junction, Vermont 05009, United States
    • Laura Jensen, MPH · Contact · Laura.Jensen@va.gov · 802-295-9363
    • Florian R Schroeck, MD, MS · Principal investigator
07

References and documents

Publications

  • Kukreja JB, Schroeck FR, Lotan Y, Gore JL, Ullman R, Lipman RR, Murray MBB, Chisolm S; Cystoscopy Discomfort Working Group; Smith AB. Discomfort and relieving factors among patients with bladder cancer undergoing office-based cystoscopy. Urol Oncol. 2022 Jan;40(1):9.e19-9.e27. doi: 10.1016/j.urolonc.2021.05.009. Epub 2021 Jun 20. PubMed 34162499 ↗
  • Smith AB, Chisolm S, Deal A, Spangler A, Quale DZ, Bangs R, Jones JM, Gore JL. Patient-centered prioritization of bladder cancer research. Cancer. 2018 Aug 1;124(15):3136-3144. doi: 10.1002/cncr.31530. Epub 2018 May 4. PubMed 29727033 ↗
  • Yeo JK, Cho DY, Oh MM, Park SS, Park MG. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial. J Endourol. 2013 Apr;27(4):459-62. doi: 10.1089/end.2012.0222. Epub 2012 Dec 5. PubMed 23009573 ↗

Individual participant data

Plan to share: Yes — De-identified clinical and quality of life data, data on intervention administration, mixed-methods data on implementation of the study interventions, and metadata will be shared via a Generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative.

Supporting information: Study protocol, Sap, Icf, Analytic code

08

Registry details

Key details

Study ID
NCT07795255
Lead sponsor
Florian Schroeck
Responsible party
Florian Schroeck (Section Chief, Urology, White River Junction Veterans Affairs Medical Center) — Sponsor-investigator
First posted
Aug 31, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 1, 2030 (estimated)
Completion
Sep 1, 2031 (estimated)
Last update
Sep 1, 2026

Study contacts

Laura L Jensen, MPH
Contact
Laura.Jensen@va.gov
802-295-9363 ext. 6953
Florian R Schroeck, MD, MS
Contact
Florian.Schroeck@va.gov
802-295-9363 ext. 6593
Florian R Schroeck, MD, MS
principal investigator · White River Junction Veterans Healthcare System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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