Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
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
Study locations (1)
University of Cincinnati
Cincinnati, Ohio, 45219