NCT05769062

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Single digit pelvic exam	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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2023-03-15
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States