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Prostate CancerSexual healthErectile dysfunctionProstate healthDigital healthBehavioralCancerMen's healthBehavioralDevice

What this study is

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.

What's being tested

  • Sex Therapy

    Intervention · BEHAVIORAL

    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.

  • Pelvic Floor Physical Therapy

    Intervention · BEHAVIORAL

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

  • Vacuum Erection Device (VED)

    Intervention · DEVICE

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

Study details

Official title
RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
Sponsor
Duke University
Conditions
Prostate Cancer · Urinary Incontinence · Erectile Dysfunction
Enrolling
30 people
Starts
2026-11
Est. completion
2029-11
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗