Bladder Full or Empty for Pelvic Radiation Therapy

This study is looking at whether having a full or empty bladder is better during radiation therapy for pelvic cancers. These cancers can be in the urinary system (genitourinary or GU), female reproductive system (gynecological or Gyn), or digestive system (gastrointestinal or GI). Currently, doctors often ask patients to have a full bladder during radiation, hoping it protects healthy organs. However, keeping the bladder consistently full can be difficult. This study will compare the effects of full and empty bladder protocols during radiation therapy. We want to see if one approach leads to fewer side effects (acute toxicity) three months after radiation. We are looking to enroll about 300 adults aged 18 and older who are eligible for radiation therapy for these types of pelvic cancers. The current recruitment status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific intervention (radiation therapy with either a full or empty bladder protocol). The study plans to enroll 300 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for acute toxicity for three months after radiation treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

BladdEr Full OR Empty for Pelvic Radiation Therapy

Recruiting

PHASE3Ages 18+InterventionalTreatment

University of California, San Diego

~300 participants

Updated 2026-02-17 on ClinicalTrials.gov

What's tested:Radiation therapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Acute toxicity

Measured over 3 months post radiation

Conditions

Pelvic Neoplasm

Where it's being run

1 sites across 1 states

California1

Study leadership

Tyler Seibert, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Tyler Seibert, MD, PhD

[email protected]

858 822 5354

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Persons, aged at least 18 years

Deemed eligible to undergo curative intent radiation therapy for primary GU, GI, or Gyn 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 such a method during study participation

For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner

Exclusion

Pregnancy

Tumor invading the bladder, as judged by the enrolling physician based on available clinical information

Contraindications to radiotherapy, including Crohn's disease and active connective tissue disorders such as scleroderma or uncontrolled lupus

Prior radiation therapy to an area requiring treatment in the present study

What this trial measures

Acute toxicity3 months post radiation
Acute any attribution GU and/or GI grade ≥2 toxicity. This will be defined as the percentage of patients with CTCAE version 5.0 GU and/or GI grade ≥2 toxicity within 3 months post radiation therapy. This will be defined as a co-primary endpoint.

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