Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

NCT05769062 | Terminated

• 1 other identifier: 202209105
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

cervical cancer; radiation; chemoradiation; pelvic floor muscle dysfunction; chronic pelvic pain

Outcome Measures

Primary Outcomes (3)

• Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam

  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.

  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

• Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam

  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.

  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

• Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam

  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.

  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

Secondary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Single-digit pelvic exam

EXPERIMENTAL

* 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.

Procedure: Single digit pelvic exam

Interventions

Single digit pelvic exam PROCEDURE

The exam takes approximately 5 minutes and uses a single digit to palpate the pelvic floor muscles, during which patients will rate pain on a scale of 0-10 at 5 paired locations.

Single-digit pelvic exam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Premal Thaker, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 15, 2023
• Study Start: May 30, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)