Clinical trial for Erectile Dysfunction Following Radical Prostatectomy
Official title Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
ClinicalTrials.gov ID: NCT07576335
What this study is testing
What is Tadalafil 5 mg?
an investigational daily tablet being studied as a potential treatment for erectile dysfunction following radical prostatectomy is designed to inhibit phosphodiesterase‑5 (PDE5), which can increase blood flow to the penis
Also referred to as Cialis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a combined program of medication, exercise, nutrition and mental‑health support can improve erectile function and urinary continence after prostate surgery.
- Who it's for
- Men scheduled for robot‑assisted radical prostatectomy who meet the trial’s eligibility criteria.
- What's involved
- Participants will take a low‑dose erectile medication, do pelvic floor and aerobic exercises, follow nutrition advice, and use online relaxation tools, plus attend regular check‑ups. The program is delivered online and participants follow it themselves.
- Time commitment
- The trial lasts about 12 months, with visits and assessments before surgery and at 6 weeks, 3, 6, and 12 months after surgery.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
- Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
- Willingness to engage in prescribed self-directed interventions.
- Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy
You likely can't join if
- Cognitive impairment such that they lack capacity to provide informed consent.
- Currently taking intracavernosal injection therapy.
- Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
- Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
- Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min).
- Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
See the full eligibility criteria
- Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
- Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
- Willingness to engage in prescribed self-directed interventions.
- Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy
- Cognitive impairment such that they lack capacity to provide informed consent.
- Currently taking intracavernosal injection therapy.
- Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
- Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
- Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min).
- Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
- Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).
- Myocardial infarction within the last 90 days.
- Stroke within the last 6 months.
- Unstable angina or angina occurring during sexual intercourse.
- New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.
- Uncontrolled arrhythmias, hypotension (\<90/50 mmHg), or uncontrolled hypertension.
- Contraindications to participating in the prescribed exercise program.
- No access to a device with internet connectivity.
The study team makes the final eligibility decision.
Where it is enrolling
- Sydney, New South Wales, Australia
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sydney, New South Wales, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.