ClinicalTrials.gg
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

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 1,740 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Florian Schroeck as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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)
05

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

06

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;

07

Study locations

5 sites
08

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, Statistical analysis plan, Informed consent form, Analytic code

Time frame: After all primary, secondary, and exploratory analyses have been performed.

Access criteria: Appropriate ethics approval as per local investigator standards. Acceptance of a Data Use Agreement.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2030, 46 months later.

Of 83 non-industry phase 3 interventional studies under Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 96. This study's planned 46 months is below that.

Counting every sponsor, half of 202 studies reached it within 50 months; a quarter within 33 and three quarters within 84.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 31, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Sep 1, 2030
CompletionEst.
Sep 1, 2031
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion