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Sex therapy and pelvic floor therapy for recovery after prostate cancer treatment

Tests telehealth sex therapy added to pelvic floor therapy in men treated for prostate cancer.

Key facts

Who runs it
Duke University
Where
Durham, United StatesSee the site
Trial code
Registry title
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Status
Recruiting
People taking part
30 people, planned
Started
Nov 2026
Expected to end
Nov 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Sex Therapy
  • Pelvic Floor Physical Therapy
  • Vacuum Erection Device (VED)
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men treated for localized prostate cancer at Duke Health who are starting pelvic floor physical therapy. It tests adding sex therapy by telehealth.

Age
18 years or older
Sex
Men only
Disease stage
Biopsy-confirmed localized prostate adenocarcinoma
Earlier treatment
Must have been treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as the main prostate cancer treatment at Duke Health, and be starting pelvic floor physical therapy as routine care. Must not have had other local or systemic prostate cancer treatment before.
Biomarker or test result
Before treatment, an erectile function score (IIEF-5) of 17 or higher, with or without aids

Main reasons for not taking part

  • Androgen deprivation therapy given or planned for prostate cancer
  • Treatment that was not nerve-sparing (when applicable)
  • Need for more prostate cancer treatment during the intervention period
  • Cognitive impairment or major psychiatric concern that would interfere with taking part
  • Cannot do pelvic floor physical therapy, penile rehabilitation, video visits or questionnaires

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol
  • History of prior local or systemic treatment for prostate cancer
  • 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
  • Recieved non-nerve-sparing treatment (when applicable)
  • Inability to complete study video visits or questionnaires

Where in United States

  • Duke University Medical CenterDurham, United StatesContact: Michael W Willis, BATaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • PFPT + Sex TherapyTreatment being tested

    Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).

    Treatment: Sex Therapy, Pelvic Floor Physical Therapy, and Vacuum Erection Device (VED)

  • PFPT Alone (Standard Care)Existing treatment, for comparison

    Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.

    Treatment: Pelvic Floor Physical Therapy and Vacuum Erection Device (VED)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
Plain-language title
Sex therapy and pelvic floor therapy for recovery after prostate cancer treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
6 November 2026