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

NCT07447895 | Recruiting DMC

• 1 other identifier: UCCC-RT-25-05
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer; Radiation Therapy Complication; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rates of urinary incontinence via EORTC-QLQ CX24

  3 months after Radiation Therapy Treatment

• Sexual symptoms via EORTC-QLQ CX24

  3 months after Radiation Therapy Treatment

• QOL as obtained from the EORTC-QLQ CX24

  3 months after Radiation Therapy Treatment

• Compliance rates with recommended standard of care schedule of dilator via self reports

  3 months after Radiation Therapy Treatment

• Evaluate changes in pelvic floor muscle function using the validated Brink scale

  At Baseline and at 3 months after Radiation Therapy Treatment

Study Arms (1)

Pelvic floor physical therapy

EXPERIMENTAL

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

Interventions

Pelvic floor physical therapy PROCEDURE

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.

Pelvic floor physical therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1\. Participants must be female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any previous therapeutic pelvic radiation.
• Non-English speaking.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pelvic Floor Disorders

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; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Sarah Sittenfeld

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): April 16, 2029
• Study Completion (Estimated): April 16, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)