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Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

Non Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Gynecologic Cancer

NCT05769062

Washington University School of Medicine

20 August 2025

FAQs

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