Actively Recruiting
BladdEr Full OR Empty for Pelvic Radiation Therapy
Led by University of California, San Diego · Updated on 2026-02-17
300
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of empty versus full bladder protocols during radiation therapy for common pelvic cancers affecting the genitourinary, gynecological, and gastrointestinal systems. Radiation therapy is important in treating these malignancies, but the typical full bladder approach can cause variations in bladder size, potentially altering radiation dose distribution and side effects. This study addresses the lack of prospective data comparing these two bladder preparation methods. Participants are randomly assigned to either a full bladder or empty bladder protocol for their CT simulation and subsequent radiation treatments. The full bladder protocol involves patients maintaining a full bladder as traditionally recommended, while the empty bladder protocol involves patients having an empty bladder during treatment. Both protocols are evaluated to understand their impact on radiation delivery and treatment outcomes. During the study, participants will undergo CT simulations and receive radiation therapy according to their assigned bladder protocol. Researchers will assess acute toxicity within three months after radiation treatment, focusing on side effects related to radiation exposure. Participants will be monitored throughout the treatment period to track any changes or complications. The study duration and follow-up extend at least three months post-radiation to evaluate these outcomes effectively.
CONDITIONS
Brief Title
BladdEr Full OR Empty for Pelvic Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Aged 18 years or older
- Eligible for curative intent radiation therapy for primary genitourinary, gastrointestinal, or gynecological malignancy of the pelvis
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use it during participation
- For participants able to cause pregnancy: use of condoms or other effective contraception methods with partner
You will not qualify if you...
- Pregnancy
- Tumor invading the bladder as determined by the enrolling physician
- Contraindications to radiotherapy such as Crohn's disease or active connective tissue disorders like scleroderma or uncontrolled lupus
- Prior radiation therapy to the area being treated in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiation therapy course
Participants undergo pelvic radiation therapy using either a full bladder or empty bladder protocol as randomized, with simulation and treatment sessions planned accordingly.
Multiple visits for radiation therapy sessions
Duration - 3 months post radiation
Participants are monitored for acute toxicity and outcomes up to 3 months after completing radiation therapy.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
T
Tyler Seibert, MD, PhD
R
Rana McKay, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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