Simple 5-Minute exam may spot hidden pelvic damage after cancer radiation
NCT ID NCT05769062
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
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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
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22 people
The number who actually took part.
- Started
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May 2023
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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