RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
Duke University
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.
Description
This is a two-arm, parallel-group, randomized feasibility trial conducted at Duke University Health System. Eligible adult men treated for localized prostate adenocarcinoma with erectile nerve-sparing radical prostatectomy, radiotherapy, or cryoablation at Duke Health who are initiating pelvic floor physical therapy (PFPT) will be randomized 1:1 to PFPT plus sex therapy or PFPT alone. PFPT is delivered as part of routine clinical survivorship care. All enrolled participants will receive penile rehabilitation education and a vacuum erection device (VED) as part of standard PFPT, in addition to…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria * Age 18 years or older. * Biopsy-confirmed localized prostate adenocarcinoma. * Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health. * Initiating pelvic floor physical therapy as part of routine clinical care. * Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant reca…
Interventions
- BehavioralSex 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.
- BehavioralPelvic Floor Physical Therapy
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
- DeviceVacuum 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.
Location
- Duke University Medical CenterDurham, North Carolina