Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Early Erectile Rehabilitation with Sildenafil for Men After Rectal Cancer Surgery

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on helping men who have undergone a surgery called proctectomy for rectal cancer. The study is investigating the use of a medication called Sildenafil, which is commonly known for treating erectile dysfunction. The purpose of the study is to see if taking Sildenafil early after surgery can help prevent long-term erectile dysfunction, which is a common issue after this type of surgery.

Participants in the study will be randomly assigned to receive either Sildenafil or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about a year, and during this time, participants will take the medication and have regular check-ups to monitor their progress. The main goal is to see if Sildenafil can help maintain normal erectile function one year after surgery.

Throughout the study, participants will be asked to complete questionnaires about their erectile function and overall quality of life. These assessments will help researchers understand the effectiveness of Sildenafil in improving sexual health and well-being after surgery. The study aims to provide valuable insights into the benefits of early erectile rehabilitation for men recovering from rectal cancer surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, recent surgery for rectal cancer, and normal erectile function before surgery.

    Consent is required, and understanding of the study details is necessary.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes the International Index of Erectile Function (IIEF) score, which evaluates erectile function through specific questions.

  3. Step 3

    Medication administration

    The medication used in the study is Sildenafil, administered as a 50 mg film-coated tablet for oral use.

    The treatment duration is 10 months, with regular intake required to ensure compliance.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at various intervals: immediately after surgery (D0), and at 3 months (M3), 6 months (M6), 9 months (M9), and 12 months (M12) post-surgery.

    These assessments include the IIEF score, quality of life evaluations, and other health-related scores.

  5. Step 5

    Monitoring and evaluation

    Throughout the study, the number of unused tablets is monitored to assess compliance.

    The occurrence of any adverse events is recorded at each follow-up interval.

  6. Step 6

    Final evaluation

    At 12 months post-surgery, a final evaluation is conducted to determine the effectiveness of the treatment in preventing long-term erectile dysfunction.

    The primary measure of success is achieving a specific score on the IIEF.

Who can join the trial?

7 criteria

  • Men aged 18 to 70 years
  • Patients who had surgery for cancer in the lower or middle part of the rectum, with the entire rectum removed and reconnected to the colon or anus, about 30 days ago (plus or minus 7 days), and had normal erectile function before surgery. **Erectile function** refers to the ability to have and maintain an erection.
  • Sexually active patients who did not receive treatment for erectile function before the surgery
  • Patients who have a stable sexual partner, whether male or female
  • Adults who have read and understood the information provided and signed the consent form
  • Patients who are part of a social security plan
  • Patients who had **conservative nerve surgery**, meaning the surgery aimed to protect the nerves involved in erectile function

Who cannot join the trial?

4 criteria

  • Women cannot participate in this study.
  • Men who have not undergone a proctectomy for rectal cancer cannot participate. A proctectomy is a surgery to remove part or all of the rectum.
  • Individuals who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Individuals who belong to a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sildenafil is a medication used in this trial to help with erectile rehabilitation. It is being tested to see if it can prevent long-term erectile dysfunction in patients who have undergone proctectomy for rectal cancer. The goal is to determine if taking Sildenafil early after surgery can improve erectile function 12 months later.

What is already known about the treatment

Sildenafil – Sildenafil is administered orally in the form of tablets. It is currently well-established in medical literature as a treatment for erectile dysfunction. The main therapeutic indication for Sildenafil in this context is to aid in erectile rehabilitation for men who have undergone proctectomy for rectal cancer. At the molecular level, Sildenafil works by inhibiting an enzyme called phosphodiesterase type 5 (PDE5), which results in increased blood flow to the penis and helps achieve and maintain an erection. It is classified pharmacologically as a phosphodiesterase inhibitor.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as a growth called a polyp on the inner lining of the rectum, which can become cancerous over time. As the cancer progresses, it can invade deeper layers of the rectal wall and spread to nearby lymph nodes or other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may spread to distant organs. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515431-30-00Protocol code2019/0398/HPEstimated enrolment188 patientsSponsorCentre Hospitalier Universitaire Rouen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.