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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Florian Schroeck
Study ID
NCT07795255
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer
  • Hematuria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Dwell time 5-10 minutes — DRUG
    Numbing medication dwell time, 5-10 minutes.
  • Dwell Time more than 10 minutes — DRUG
    Numbing medication dwell time, \>10 minutes.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
1,740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Music and short dwell time
    Listening to music and 5-10 minute numbing medication dwell time
  • Active Comparator: No music and short dwell time
    5 - 10 minute numbing medication dwell time
  • Experimental: Music and long dwell time
    Listening to music and \>10 minute numbing medication dwell time
  • Experimental: No music and long dwell time
    \>10 minute numbing medication dwell time

Primary Outcome Measure

Pain level [ Time Frame: Assessed immediately after each cystoscopy procedure. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Kaelin Hodges
[email protected]
Charles Peyton, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Deborah Usinger
[email protected]
Angela B Smith, MD, MS (PRINCIPAL_INVESTIGATOR)
Novant Health New Hanover Regional Medical CenterWilmingtonNorth Carolina28401
Lynette McFayden
[email protected]
Ibardo Zambrano, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Sonobia Garrett
[email protected]
Yair Lotan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of North Carolina· Chapel Hill, NCNovant Health New Hanover Regional Medical Center· Wilmington, NCUniversity of Texas Southwestern Medical Center· Dallas, TX

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