Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- University of Cincinnati
- Study ID
- NCT07447895
- Status
- Recruiting
Conditions
- Cervical Cancer
- Pelvic Floor Disorders
- Radiation Therapy Complication
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pelvic floor physical therapy — PROCEDUREFour 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.
Study 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.
Key Dates
- Start date
- Apr 16, 2026
- Status verified
- Apr 2026
- Primary completion
- Apr 16, 2029
- Completion
- Apr 16, 2030
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Pelvic floor physical therapyPatients 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.
Primary Outcome Measure
Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey [ Time Frame: 3 months after Radiation Therapy Treatment ]
Central Contacts
- UCCC Clinical Trials Office513-584-7698
- Sarah Sittenfeld
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | UCCC Clinical Trials Office Sarah Sittenfeld |
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