An interventional study of Pelvic floor physical therapy in Cervical Cancer, Radiation Therapy Complication and Pelvic Floor Disorders, sponsored by University of Cincinnati. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Supportive care
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 28 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Pelvic 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.
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
Rates of urinary incontinence via EORTC-QLQ CX24
1\. 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.
Time frame: 3 months after Radiation Therapy Treatment
Sexual symptoms via EORTC-QLQ CX24
1\. 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.
Time frame: 3 months after Radiation Therapy Treatment
QOL as obtained from the EORTC-QLQ CX24
1\. 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.
Time frame: 3 months after Radiation Therapy Treatment
Compliance rates with recommended standard of care schedule of dilator via self reports
2\. 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. 1. Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage. 2. Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation
Time frame: 3 months after Radiation Therapy Treatment
Evaluate changes in pelvic floor muscle function using the validated Brink scale
3\. 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.
Time frame: At Baseline and at 3 months after Radiation Therapy Treatment
Plan to share: Undecided
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University of Cincinnati