Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

Not Applicable

Active, not recruiting

• Conditions: Gynecologic Cancer
• Interventions: Procedure: Single digit pelvic exam

• Registration Number: NCT05769062
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-15
• Study Start: 2023-05-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-digit pelvic exam	Single digit pelvic exam	* 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.

Primary Outcome Measures

Name	Time	Method
Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam	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	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.
Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam	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	An exam will be considered positive for PFMD if pain at any examined site is reported as \>4 out of 10. The PFIQ-7 includes 7 items each repeated across three domains and provides a scaled score and total score indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire does not have an established severity scale, and therefore will be analyzed as a simple continuous variable.
Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam	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	An exam will be considered positive for PFMD if pain at any examined site is reported as \>4 out of 10. The PFDI-20 includes 20 items in three domains and provides a scaled score of 0-100 indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire will be considered positive if the scaled score is greater than or equal to 16, indicating at least "moderate distress" and otherwise will be analyzed as a continuous variable.

Secondary Outcome Measures

Name	Time	Method
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFIQ-7 scores	Through completion of follow-up (estimated to be 6 months)	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using pelvic exam	Through completion of follow-up (estimated to be 6 months)	Continuous variables of scales and total scores will be calculated for the exam at each time point and represented in spider-type plots. Results of the exam will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam	Through completion of follow-up (estimated to be 6 months)	Continuous variables of scales and total scores, as well as specific scores for radiation-exposed structures on exam, will be compared to dosimetric assessments of exposure of pelvic floor structures.
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the EORTC QLQ-CX2 scores	Through completion of follow-up (estimated to be 6 months)	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFDI-20 scores	Through completion of follow-up (estimated to be 6 months)	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Determine structure level radiation dose to complex functional pelvic structures	Through completion of follow-up (estimated to be 6 months)	Standard dosimetric values will be calculated for each specific pelvic floor structure evaluated on exam.
Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls	Through completion of follow-up (estimated to be 6 months)	Historical controls will be queried via chart review for dosimetric values in archived radiation treatment plans and compared to current gynecologic radiation standards. These patients will also undergo thorough chart review for subsequent diagnoses of pelvic floor-related disorders and compared to the diagnosis rate using the proposed screening tools in this study.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States