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New program aims to restore sexual function after prostate cancer surgery

NCT ID NCT07576335

Disease control Sponsor: Surgical Outcomes Research Centre (SOuRCe) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This trial tests whether a combination of a daily erectile medication, pelvic floor exercises, aerobic exercise, dietary advice, and mental health support can improve erectile function and urinary control in men after robot-assisted prostate removal for prostate cancer. Sixty-four men will be randomly assigned to either the program plus standard care or standard care alone. The study is conducted virtually and aims to find a scalable, low-cost way to improve recovery.

What this could mean

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

Active substance
Tadalafil 5 mg (a low-dose erectile medication) plus pelvic floor muscle training, aerobic exercise, dietary guidance, and psychological support
What this could lead to
If it works, this could provide a practical, low-cost program to help men recover erectile and urinary function after prostate surgery.
What could go wrong
This is a small, early-phase trial with only 64 participants, so results may not apply to everyone. The program is self-directed, so adherence may vary.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

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

Started

Aug 2026

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: 1. Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer. 2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery. 3. Willingness to engage in prescribed self-directed interventions. 4. Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy Exclusion Criteria: 1. Cognitive impairment such that they lack capacity to provide informed consent. 2. Currently taking intracavernosal injection therapy. 3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function. 4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use. 5. Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min). 6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4. 7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). 8. Myocardial infarction within the last 90 days. 9. Stroke within the last 6 months. 10. Unstable angina or angina occurring during sexual intercourse. 11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months. 12. Uncontrolled arrhythmias, hypotension (\<90/50 mmHg), or uncontrolled hypertension. 13. Contraindications to participating in the prescribed exercise program. 14. No access to a device with internet connectivity.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prostate cancer Urinary Incontinence

As listed by the trial registrant

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

Erectile dysfunction following radical prostatectomy Prostate cancer Urinary incontinence following surgical procedure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chris O'Brien Lifehouse

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Concord Repatriation General Hospital (CRGH)

    RECRUITING

    Sydney, New South Wales, 2139, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, New South Wales, 2050, Australia

More trials for these conditions

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