This clinical trial investigates the use of pelvic physical therapy prior to pelvic radiation for reducing pelvic pain and painful or difficult sexual intercourse (dsypareunia) in female patients undergoing pelvic radiation for cervical, vaginal, vulvar, uterine, or anal cancers. Pelvic radiotherapy can increase the risk for sexual dysfunction and pelvic pain in women. Pelvic health physical therapy is a niche practice in physical therapy offering specialized rehabilitation of the pelvic floor muscles. Current best practice for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles. This study seeks to implement a pre-rehabilitative program in pelvic health physical therapy to address pelvic pain and dyspareunia in female patients undergoing pelvic radiation for cervical, vaginal, vulvar, uterine, or anal cancers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06059586.
Locations matching your search criteria
United States
Indiana
Carmel
IU Health North HospitalStatus: Active
Contact: Namita Agrawal
Phone: 317-688-5660
PRIMARY OBJECTIVE:
I. To demonstrate the feasibility of implementing a pre-rehabilitation pelvic health physical therapy model, to increase patient dilator adherence, patient visit attendance, and scheduled visits within suggested time frame.
SECONDARY OBJECTIVE:
I. To demonstrate reduced pelvic pain and dyspareunia after pelvic health physical therapy pre-rehabilitation and five follow up visits in a 4-month period.
OUTLINE:
Patients attend a pelvic health physical therapy visit where they undergo a pelvic floor muscle examination and receive vaginal dilator education within 4 weeks prior to initiating their standard of care (SOC) radiation therapy. At 4 weeks post-radiation therapy, patients receive a vaginal dilator and review vaginal dilator education. Patients attend pelvic health physical therapy follow-up visits including pelvic floor muscle examinations at 6, 8, 12, and 16 weeks post-radiation therapy. Patients may also receive a therapeutic exercise prescription at the discretion of the treating physical therapist.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIU Health North Hospital
Principal InvestigatorNamita Agrawal
