Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
1 other identifier
interventional
1,740
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2026
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
Study Completion
Last participant's last visit for all outcomes
September 1, 2031
September 1, 2026
August 1, 2026
3.8 years
August 13, 2026
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain level
Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain
Assessed immediately after each cystoscopy procedure.
Secondary Outcomes (3)
Pain intensity
Assessed immediately after each cystoscopy procedure.
Level of emotional distress and anxiety
Assessed immediately after each cystoscopy procedure.
Patient Satisfaction
Assessed immediately after each cystoscopy procedure;
Study Arms (4)
Music and short dwell time
EXPERIMENTALListening to music and 5-10 minute numbing medication dwell time
No music and short dwell time
ACTIVE COMPARATOR5 - 10 minute numbing medication dwell time
Music and long dwell time
EXPERIMENTALListening to music and \>10 minute numbing medication dwell time
No music and long dwell time
EXPERIMENTAL\>10 minute numbing medication dwell time
Interventions
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.
Numbing medication dwell time, 5-10 minutes.
Numbing medication dwell time, \>10 minutes.
Eligibility Criteria
You may qualify if:
- Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florian Schroecklead
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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
Related Publications (3)
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.
PMID: 34162499BACKGROUNDSmith 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.
PMID: 29727033BACKGROUNDYeo 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.
PMID: 23009573BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florian R Schroeck, MD, MS
White River Junction Veterans Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Section Chief, Urology
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 31, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2031
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.