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Recruiting

NCT Number: NCT07447895

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.

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Male Urogenital Diseases Neoplasms Neoplasms by Site Pelvic Floor Disorders Pregnancy Complications Radiation Therapy Complication Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location status: Recruiting

Location contact

Sarah Sittenfeld

CONTACT

UCCC Clinical Trials Office

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rates of urinary incontinence via EORTC-QLQ CX24

    Time frame: 3 months after Radiation Therapy Treatment

    • 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.

  2. Sexual symptoms via EORTC-QLQ CX24

    Time frame: 3 months after Radiation Therapy Treatment

    • 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. QOL as obtained from the EORTC-QLQ CX24

    Time frame: 3 months after Radiation Therapy Treatment

    • 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.

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

    Time frame: 3 months after Radiation Therapy Treatment

    • 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

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

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

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Sittenfeld

CONTACT

UCCC Clinical Trials Office

CONTACT

[email protected]

513-584-7698

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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