Clinical trial · Interventional
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Former PI left the institution so enrollment was closed early.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single digit pelvic exam | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-digit pelvic exam
- description
- * Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points. * The patient will also undergo a standard of care MRI prior to starting treatment.
- interventionNames
- Procedure: Single digit pelvic exam
Primary outcomes (3)
- measure
- Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam
- timeFrame
- Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
- description
- An exam will be considered positive for PFMD if pain at any examined site is reported as greater than or equal to four (\>4) out of 10. The EORTC QLQ-CX2 contains 24 items scored 1-4 by frequency with which the patient experiences each. The minimum possible score is 24, and maximum 96, with higher scores indicating worse quality of life. The questionnaire will be considered positive if any vaginal, sexual, or genitourinary module question is rated 4 and otherwise will be analyzed as a continuous variable.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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