Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Starting soon · Not applicable

Conditions studied: Prostate Cancer, Urinary Incontinence, Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT07685249

Run by

Duke University

People needed

30

Starts

2026-08-01

Expected to finish

2028-08-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.
• Able to read and understand English to complete patient-reported outcome measures.
• Ability to provide informed consent.

You may not qualify if…

• Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.
• Recieved non-nerve-sparing treatment (when applicable).
• Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
• Need for additional or secondary prostate cancer treatment during the intervention period.
• Documented cognitive impairment or impairment that would interfere with participation.
• Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.
• Inability to complete study video visits or questionnaires.
• History of prior local or systemic treatment for prostate cancer

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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