MedTrace Logo

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

NCT05769062 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Premal Thaker, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769062 on ClinicalTrials.gov