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Simple 5-Minute exam may spot hidden pelvic damage after cancer radiation

NCT ID NCT05769062

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to find a better way to detect pelvic floor problems caused by radiation treatment for gynecologic cancer. Researchers tested a 5-minute single-digit pelvic exam on 22 patients undergoing chemoradiotherapy for cervical cancer. The goal was to see if this exam could identify areas of pain and injury better than standard patient questionnaires, and to use that information to improve future radiation planning. The trial was terminated early, so results are limited.

What this could mean

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

What this could lead to
If successful, this could lead to a simple exam-based tool to identify pelvic floor damage early and guide radiation planning to reduce long-term side effects.
What could go wrong
The trial was terminated early with only 22 participants, so results are limited and may not apply broadly. The exam is still experimental and not proven to improve outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

22 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

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

Female participants only

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 - Prospective Cohort * Undergoing primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent). * At least 18 years of age. * English speaker. * Able to understand and willing to sign an IRB approved written informed consent document. Exclusion Criteria - Prospective Cohort * Received any form of pelvic radiation (excepting diagnostic studies). * Currently taking and does not plan to take anti-estrogenic hormonal therapy. * Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease. * Currently being treated for a chronic non-cancer pain condition (treatment for pain after enrollment is acceptable). Inclusion Criteria - Retrospective Cohort (historical control) * Received primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent). * At least 18 years of age. Exclusion Criteria - Retrospective Cohort (historical control) * Received any form of pelvic radiation (excepting diagnostic studies). * Took anti-estrogenic hormonal therapy during treatment or in the 6 months following treatment. * Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease at the start of treatment. * Simultaneously treated for a chronic non-cancer pain condition at the start of treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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