Bladder (Urothelial, Transitional Cell) CancerPhase 3NCT07795255
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
A Phase 3 study testing Headphones, Dwell time 5-10 minutes and Dwell Time more than 10 minutes in people with Bladder (Urothelial, Transitional Cell) Cancer and Hematuria, run by Florian Schroeck at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
- What is being tested?
- Headphones, Dwell time 5-10 minutes and Dwell Time more than 10 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,740 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Nov 2026to 1 Sep 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Kaelin Hodges, kaelins@uab.edu
Charles Peyton, MD
University of North Carolina
Chapel Hill, North Carolina, 27599
Deborah Usinger, dusinger@email.unc.edu
Angela B Smith, MD, MS
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sonobia Garrett, sonobia.garrett@utsouthwestern.edu
Yair Lotan, MD
White River Junction Veterans Healthcare System
White River Junction, Vermont, 05009
Laura Jensen, MPH, 802-295-9363 ext. 6953, Laura.Jensen@va.gov
Florian R Schroeck, MD, MS
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Lynette McFayden, Lynette.McFayden@novanthealth.org
Ibardo Zambrano, MD
About this study
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.
- Being tested
- Headphones, Dwell time 5-10 minutes, Dwell Time more than 10 minutes
- Keywords
- Cystoscopy, Bladder Cancer, Hematuria, Microhematuria
- Medical subject headings
- Neoplasms, Hematuria, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeadphonesDevice
Also called Music
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.
Dwell time 5-10 minutesDrug
Also called Short Lidocaine
Numbing medication dwell time, 5-10 minutes.
Dwell Time more than 10 minutesDrug
Also called Long Lidocaine
Numbing medication dwell time, >10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Music and short dwell time | Experimental | Listening to music and 5-10 minute numbing medication dwell time Receives: Device: Headphones; Drug: Dwell time 5-10 minutes |
| No music and short dwell time | Active comparator | 5 - 10 minute numbing medication dwell time Receives: Drug: Dwell time 5-10 minutes |
| Music and long dwell time | Experimental | Listening to music and >10 minute numbing medication dwell time Receives: Device: Headphones; Drug: Dwell Time more than 10 minutes |
| No music and long dwell time | Experimental | >10 minute numbing medication dwell time Receives: Drug: Dwell Time more than 10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain
Measured: Assessed immediately after each cystoscopy procedure.
Secondary outcomes (3)
Pain intensity
PROMIS Pain Intensity Scale v2.0 - Pain Intensity 3a. Scale is 1-5; higher number indicates higher level of pain.
Measured: Assessed immediately after each cystoscopy procedure.
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.
Measured: Assessed immediately after each cystoscopy procedure.
Patient Satisfaction
Client Satisfaction Questionnaire (CSQ-3). Scale is 1-4; higher number indicates higher level of satisfaction.
Measured: Assessed immediately after each cystoscopy procedure;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial design
- Masking
- None (open label)
- Enrolment
- 1,740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florian Schroeck
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Florian Schroeck, White River Junction Veterans Affairs Medical Center
- Investigators
- Florian R Schroeck, MD, MS, Principal investigator, White River Junction Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795255
- Sponsor's protocol ID
- R01CA303719
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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 34162499Smith 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 29727033Yeo 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
- ClinicalTrials.gov ID
- NCT07795255
- Acronym / sponsor ID
- R01CA303719
- Keywords
- Cystoscopy, Bladder Cancer, Hematuria, Microhematuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- Florian SchroeckUS federal agency
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 x 2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Music and short dwell time | Experimental | Device: Headphones, Drug: Dwell time 5-10 minutesListening to music and 5-10 minute numbing medication dwell time |
| No music and short dwell time | Active comparator | Drug: Dwell time 5-10 minutes5 - 10 minute numbing medication dwell time |
| Music and long dwell time | Experimental | Device: Headphones, Drug: Dwell Time more than 10 minutesListening to music and >10 minute numbing medication dwell time |
| No music and long dwell time | Experimental | Drug: Dwell Time more than 10 minutes>10 minute numbing medication dwell time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeadphonesAlso: MusicMusic 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. | Device | Music and long dwell time, Music and short dwell time |
| Dwell time 5-10 minutesAlso: Short LidocaineNumbing medication dwell time, 5-10 minutes. | Drug | Music and short dwell time, No music and short dwell time |
| Dwell Time more than 10 minutesAlso: Long LidocaineNumbing medication dwell time, >10 minutes. | Drug | Music and long dwell time, No music and long dwell time |
Primary outcome
Pain level
Time frame: Assessed immediately after each cystoscopy procedure.
Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain
3 secondary outcomes
Pain intensity
Time frame: Assessed immediately after each cystoscopy procedure.
Level of emotional distress and anxiety
Time frame: Assessed immediately after each cystoscopy procedure.
Patient Satisfaction
Time frame: Assessed immediately after each cystoscopy procedure;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 34162499Kukreja 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.
- Background: PubMed 29727033Smith 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.
- Background: PubMed 23009573Yeo 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.
- Individual participant dataSharing planned: 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.
Related trials for Bladder (Urothelial, Transitional Cell) Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
Bladder Cancer, Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian R Schroeck, MD, MS principal investigator
White River Junction Veterans Healthcare System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Headphones, Dwell time 5-10 minutes and Dwell Time more than 10 minutes in people with Bladder (Urothelial, Transitional Cell) Cancer and Hematuria, run by Florian Schroeck at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura L Jensen, MPH (802-295-9363 ext. 6953, Laura.Jensen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Assessed immediately after each cystoscopy procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07795255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.