Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sex Therapy
- Pelvic Floor Physical Therapy
- Vacuum Erection Device (VED)
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov