NCT05242770

Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-week regimen is necessary for true improvement of symptoms. Investigators aim to see if this tense regimen is feasible for survivors. Investigators also aim to see if patients have an improvement in their sexual function and quality of life.

Detailed description

Primary Objective(s): To determine the feasibility of an intensive pelvic physical therapy intervention with gynecologic cancer survivors reporting sexual dysfunction. Feasibility will be determined by accrual, retention, and adherence. Secondary Objective(s): * To demonstrate preliminary efficacy of the pelvic physical therapy intervention on sexual function in gynecologic cancer survivors. Sexual function will be measured three times: at time of randomization (T0), after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization (T1), and 3 months after T1 (T2). * To demonstrate preliminary efficacy of the pelvic physical therapy intervention on health-related quality of life in gynecologic cancer survivors. Quality of life will be measured at three times (T0) at time of randomization, (T1) after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization, and (T2) 3 months after T1

Conditions

• Gynecologic Cancer
• Sexual Dysfunction

Interventions

Type	Name	Description
OTHER	Control Arm	Participants randomized to this arm will only receive educational pamphlets with resources for sexual dysfunction and will not participate in physical therapy. Participants will be contacted at 3 months and 6 months to fill out two questionnaires about sexual function and quality of life. After 6months, if participants desire a referral to physical therapy, investigators will provide a referral.
OTHER	Physical Therapy Arm	Participants will receive a referral to begin a pelvic physical therapy regimen. Participants will complete the sexual function and quality of life questionnaires after completion of the physical therapy regimen and again 3 months after. There will be a brief exit interview.
OTHER	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)	Questionnaire designed to measure cancer patients' physical, psychological and social functions
OTHER	Female Sexual Function Index (FSFI)	19-item self-report inventory designed to assess female sexual function.
OTHER	Exit Interview	11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.

Timeline

• Start date: 2022-03-28
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2022-02-16
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States