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

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: Cervical Cancer; Pelvic Floor Disorders; Radiation Therapy Complication
• Intervention / Treatment: Procedure: Pelvic floor physical therapy

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

• Study Contact: Name: UCCC Clinical Trials Office; Phone Number: 513-584-7698; Email: cancer@uchealth.com
• 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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	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	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.; Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage.; 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	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

• Sponsor: University of Cincinnati

Study record dates

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: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Pelvic Floor Disorders
• 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