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Bladder battle: full or empty to ease radiation side effects?

NCT ID NCT06651697

Symptom relief Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether having a full or empty bladder during pelvic radiation therapy reduces short-term side effects like bladder or bowel irritation. 300 adults with pelvic cancers (genitourinary, gynecological, or gastrointestinal) will be randomly assigned to one of the two bladder protocols. The main goal is to see which approach leads to fewer moderate-to-severe side effects within 3 months after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiation therapy with full or empty bladder protocol
What this could lead to
If this trial succeeds, it could show that a simple change in bladder filling during radiation reduces short-term side effects like bladder or bowel irritation.
What could go wrong
This is a Phase 3 trial, but the benefit may be small or not apply to all pelvic cancers. Side effects from radiation itself remain a risk regardless of bladder fullness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Pelvic Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • University of California, San Diego

    RECRUITING

    San Diego, California, 92093, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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