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NOT YET RECRUITING
NCT07685249
NA

Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment. All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone. Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.

Official title: RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2029-09

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Sex Therapy

Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (\~45 minutes) over 6 months delivered by a psychologist.

BEHAVIORAL

Pelvic Floor Physical Therapy

Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.

DEVICE

Vacuum Erection Device (VED)

FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States