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

NCT ID: NCT07447895Sponsor: University of CincinnatiLast updated: 2026-04-23

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.

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.

Arms & interventions

  • ProcedurePelvic 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.

Outcome measures

Primary

  • 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.

    Time frame: 3 months after Radiation Therapy Treatment

Secondary

  • Rates of urinary incontinence via EORTC-QLQ CX24

    Time frame: 3 months after Radiation Therapy Treatment

  • Sexual symptoms via EORTC-QLQ CX24

    Time frame: 3 months after Radiation Therapy Treatment

  • QOL as obtained from the EORTC-QLQ CX24

    Time frame: 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

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

    Time frame: At Baseline and at 3 months after Radiation Therapy Treatment

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Cincinnati

Cincinnati, Ohio, 45219

Recruiting
UCCC Clinical Trials Office · Contact
Sarah Sittenfeld · Contact