Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies

April 20, 2026 updated by: Sarah Sittenfeld, University of Cincinnati
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. The objective is to determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sarah Sittenfeld

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
          • UCCC Clinical Trials Office
        • Contact:
          • Sarah Sittenfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must be female.
  2. Patients must be 18 years old or older.
  3. Any patient with invasive cervical cancer who is planned for definitive chemoradiation.
  4. Plan to receive a minimum dose of 45Gy to pelvis per investigator.
  5. Willing to undergo pelvic floor physical therapy.

Exclusion Criteria:

  1. Any previous therapeutic pelvic radiation.
  2. Non-English speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic floor physical therapy
Patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
Procedure: Pelvic floor physical therapy
Four weeks after completion of RT, patients will begin a standardized pelvic floor PT course. The protocol will include two 1-hour physical therapy appointments focused on pelvic floor muscle training, dilator training and education. These sessions will be 4 weeks apart and performed by a pelvic floor physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey
Time Frame: 3 months after Radiation Therapy Treatment

To determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.
3 months after Radiation Therapy Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of urinary incontinence via EORTC-QLQ CX24
Time Frame: 3 months after Radiation Therapy Treatment

1. To determine the rates of urinary incontinence 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

a. Secondary endpoints will include rates of urinary incontinence as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
3 months after Radiation Therapy Treatment
Sexual symptoms via EORTC-QLQ CX24
Time Frame: 3 months after Radiation Therapy Treatment

1. To determine sexual symptoms at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

a. Secondary endpoints will include rates of sexual symptoms as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
3 months after Radiation Therapy Treatment
QOL as obtained from the EORTC-QLQ CX24
Time Frame: 3 months after Radiation Therapy Treatment

1. To determine QOL at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

a. Secondary endpoints will include QOL as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
3 months after Radiation Therapy Treatment
Compliance rates with recommended standard of care schedule of dilator via self reports
Time Frame: 3 months after Radiation Therapy Treatment

2. To determine compliance rates with recommended standard of care schedule of dilator use at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

  1. Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage.
  2. Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation
3 months after Radiation Therapy Treatment
Evaluate changes in pelvic floor muscle function using the validated Brink scale
Time Frame: At Baseline and at 3 months after Radiation Therapy Treatment

3. To evaluate changes in pelvic floor muscle function at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.

a. Descriptive analysis of pelvic floor muscle function (strength, coordination, endurance objectively graded using the validated Brink scale) at baseline and follow up, along with participant reported compliance with home exercise course will also be collected and reported.
At Baseline and at 3 months after Radiation Therapy Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

April 16, 2029

Study Completion (Estimated)

April 16, 2030

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCC-RT-25-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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