Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
TerminatedNot applicableNCT05769062
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.
Study details
- Official title
- Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
- Conditions
- Gynecologic Cancer
- Interventions
- Procedure: Single digit pelvic exam
- Sponsor
- Washington University School of Medicine
- Start date
- 2023-05-30
- Primary completion
- 2025-10-10
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05769062