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Talking about sex after cancer: telehealth therapy may improve recovery

NCT ID NCT07685249

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests whether adding telehealth sex therapy to standard pelvic floor physical therapy helps men recover urinary and sexual function after prostate cancer treatment. All participants receive pelvic floor therapy and education on using a vacuum erection device. Half are randomly assigned to also have about ten sex therapy sessions over six months, delivered by a psychologist via video. Researchers will measure whether this combined approach is practical and acceptable for patients, and track urinary and sexual health through questionnaires over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telehealth sex therapy plus pelvic floor physical therapy
What this could lead to
If successful, this approach could offer a practical, non-drug way to improve sexual and urinary recovery after prostate cancer treatment.
What could go wrong
This is a small feasibility trial with only 30 participants, so results may not apply widely. The sex therapy requires a significant time commitment (10 sessions over 6 months).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prostate adenocarcinoma prostate cancer Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction Prostate cancer Urinary incontinence

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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