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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months."
  • "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."
  • "The sex therapy intervention is delivered by telehealth as 10 sessions of approximately 45 minutes over 6 months."
  • "Semi-structured qualitative interviews will be offered at 6 and 12 months post-baseline."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Duke Health study tests whether sex therapy by video visits is practical and acceptable for adult men treated for prostate cancer that has not spread. All men get physical therapy for the pelvic floor muscles, which help with bladder control, and education on helping erections recover. Men are assigned by chance to get this care with or without sex therapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are a man age 18 or older.
  • Have prostate adenocarcinoma, a type of cancer, confirmed by a tissue sample and limited to the prostate area.
  • Had your main prostate cancer treatment at Duke Health: surgery to remove the prostate while sparing nerves, radiation, or treatment that freezes the cancer.
  • Are starting pelvic floor physical therapy as part of your usual care.
  • Had a score of at least 17 on the IIEF-5 erection survey before treatment, with or without erection aids. This can be checked through recent medical records or your memory of the month before treatment.
  • Can read and understand English to complete study surveys.
  • Can understand the study and agree to take part.

Who can't join

  • Have had hormone treatment that lowers male hormones for prostate cancer, or plan to have it during the study or follow-up.
  • Had treatment that did not spare nerves, when this applies.
  • Cannot take part in pelvic floor physical therapy or the plan to help erections recover.
  • Need more prostate cancer treatment during the study treatment period.
  • Have a recorded problem with thinking or another impairment that would prevent participation.
  • Have a major mental health concern, such as schizophrenia, that would prevent you from agreeing to or taking part in the study.
  • Cannot complete study video visits or surveys.
  • Had prostate cancer treatment before your main treatment, either in the prostate area or throughout the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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. Exclusion Criteria * 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

Study sites (1)

NC