Recruiting

Telehealth Sex Therapy

Sponsor:

Duke University

Code:

NCT07685249

Conditions

Prostate Cancer

Urinary Incontinence

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sex Therapy

Pelvic Floor Physical Therapy

Vacuum Erection Device (VED)

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Urinary Incontinence

Erectile Dysfunction

Study ID

NCT07685249

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PFPT + Sex Therapy

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

active comparator: PFPT Alone (Standard Care)

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

Interventions

Sex Therapy

Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (\~45 minutes) over 6 months delivered by a psychologist.

Pelvic Floor Physical Therapy

Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.

Vacuum Erection Device (VED)

FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Primary outcome measure

  • Recruitment feasibility as measured by number of participants recruited [ Time Frame: From initiation of recruitment to completion of accrual, up to 1 year ]
  • Enrollment feasibility, as measured by consent rate [ Time Frame: From initiation of recruitment to completion of accrual, up to 1 year ]
  • Randomization feasibility [ Time Frame: From initiation of recruitment to completion of accrual, up to 1 year ]
  • Retention feasibility [ Time Frame: 12 months ]
  • Number of participants who complete study assessments [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months ]
  • Number of participants who participate in pelvic floor physical therapy (PFPT) [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months ]
  • Number of participants who participate in sex therapy [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months ]
  • Number of participants who use recommended penile rehabilitation [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months ]
  • Fidelity-monitoring feasibility [ Time Frame: During the 6-Month sex therapy intervention window ]

Central Contacts and Locations

Central contacts

Michael W Willis, BA

919-681-8437michael.w.willis@duke.edu

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michael W Willis, BA

919-681-8437michael.w.willis@duke.edu

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Principal Investigator:

Rebecca A Shelby, PhD

More Information

Sponsor

Duke University

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Pelvic Floor Physical Therapy
  • Sex Therapy
  • Penile Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Duke University on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.