Actively Recruiting
Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
Led by University of Cincinnati · Updated on 2026-04-23
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of pelvic floor physical therapy in women undergoing pelvic external beam radiation therapy for cervical cancer. This phase II single-arm study aims to evaluate the rate of fecal incontinence three months after radiation therapy in women treated for gynecologic cancers. The main focus is to assess how pelvic floor therapy might impact complications like fecal incontinence using a validated survey tool. Participants will receive pelvic floor physical therapy starting four weeks after completing radiation treatment. The therapy includes two one-hour sessions spaced four weeks apart, focusing on pelvic floor muscle training, dilator training, and education provided by a specialized physical therapist. This intervention is offered to 28 women undergoing definitive pelvic radiation. During the study, participants will undergo assessments including surveys measuring fecal and urinary incontinence, sexual symptoms, quality of life, and pelvic floor muscle function at baseline and three months post-radiation. Researchers will also monitor adherence to dilator use through self-reports. The total study duration for each participant encompasses treatment completion, therapy sessions, and follow-up evaluations at three months to assess outcomes and safety.
CONDITIONS
Brief Title
Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Any previous therapeutic pelvic radiation.
- Non-English speaking.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration according to radiation therapy plan
Participants undergo definitive pelvic external beam radiation therapy for cervical cancer.
Visits as required for radiation therapy
Duration - Approximately 8 weeks starting 4 weeks after radiation therapy
Participants begin a standardized pelvic floor physical therapy course four weeks after completing radiation therapy, including muscle training, dilator training, and education.
2 physical therapy appointments spaced 4 weeks apart
Duration - Assessment at 3 months after radiation therapy
Participants are assessed for fecal incontinence, urinary incontinence, sexual symptoms, quality of life, and pelvic floor muscle function at 3 months after radiation therapy.
1 follow-up visit for assessments
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
S
Sarah Sittenfeld
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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