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Rehabilitation and Sex Therapy After Prostate Cancer Treatment

This study at Duke Health is for adult men who have been treated for localized prostate cancer. It aims to see if offering sex therapy through telehealth (video calls) after prostate cancer treatment is practical and helpful. You would receive routine pelvic floor physical therapy and education on penile rehabilitation, including how to use a vacuum erection device (a manual pump to help with erections). Participants are randomly assigned to one of two groups: one group gets pelvic floor physical therapy plus about ten telehealth sex therapy sessions over six months, and the other group receives only pelvic floor physical therapy. You would complete questionnaires about your urinary and sexual health for up to two years, and some short interviews at 6 and 12 months. This study is currently recruiting about 30 participants.

Study design
This is a randomized study with two groups, aiming to enroll about 30 men. Participants are randomly assigned to receive either pelvic floor physical therapy plus sex therapy, or pelvic floor physical therapy alone.
What's involved
You would have routine pelvic floor physical therapy. If in the sex therapy group, you would have about ten telehealth sessions over six months. You would also complete questionnaires and possibly short interviews for up to two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07685249

Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Duke University
~30 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Sex TherapyPelvic Floor Physical TherapyVacuum Erection Device (VED)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment feasibility as measured by number of participants recruited
Measured over From initiation of recruitment to completion of accrual, up to 1 year
+8 more outcomes measured

Conditions

Prostate Cancer
Urinary Incontinence
Erectile Dysfunction

Explore related trials

Erectile DysfunctionProstate CarcinomaUrinary Incontinence

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Rebecca A Shelby, PhD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Michael W Willis, BA
[email protected]
919-681-8437
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recruitment feasibility as measured by number of participants recruitedFrom initiation of recruitment to completion of accrual, up to 1 year

    Accrual rate will be used to assess feasibility of recruiting participants to the study target of 30 participants. This feasibility trial is designed to estimate key process parameters with precision rather than to test efficacy hypotheses

  • Enrollment feasibility, as measured by consent rateFrom initiation of recruitment to completion of accrual, up to 1 year

    Consent rate will be used to assess enrollment feasibility. This measure reflects the proportion of eligible participants who provide informed consent after screening and outreach.

  • Randomization feasibilityFrom initiation of recruitment to completion of accrual, up to 1 year

    Randomization rate will be used to assess the proportion of consented eligible participants who are randomized in a 1:1 ratio to pelvic floor physical therapy (PFPT) plus sex therapy or PFPT alone.

  • Retention feasibility12 months

    Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.

  • Number of participants who complete study assessmentsBaseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months

    Assessment completion will be used to assess feasibility of longitudinal data collection across the planned study schedule. Scheduled patient-reported outcome assessments occur at baseline and during follow-up contacts.

  • Number of participants who participate in pelvic floor physical therapy (PFPT)Baseline, 3 Months, 6 Months, 9 Months, 12 Months

    Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes participation in PFPT.

  • Number of participants who participate in sex therapyBaseline, 3 Months, 6 Months, 9 Months, 12 Months

    Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes sex therapy participation in the intervention arm.

  • Number of participants who use recommended penile rehabilitationBaseline, 3 Months, 6 Months, 9 Months, 12 Months

    Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes recommended penile rehabilitation use patterns including vacuum erection device (VED) and PDE-5i use as measured via adherence logs.

  • Fidelity-monitoring feasibilityDuring the 6-Month sex therapy intervention window

    Fidelity-monitoring feasibility will be assessed using audio recording of sex therapy sessions and audit of a planned 20% sample of recordings using fidelity checklists.