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RecruitingPHASE3INTERVENTIONAL

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer

This research is investigating if a common medication for erection problems, Sildenafil (known commercially as Viagra), can help men recover their sexual function sooner after treatment for bowel cancer. When men have surgery and radiotherapy for bowel cancer, it can sometimes lead to difficulties getting or keeping an erection. This study aims to see if starting Sildenafil early can prevent these problems from lasting a long time. Researchers will compare Sildenafil with a placebo, which is a tablet that looks the same but contains no active medicine, to understand its effects better. The main goal is to find out if Sildenafil can help prevent long-term erection problems 12 months after surgery.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University Hospital, Rouen
Enrolment target
188
Start
25 Sep 2025
Estimated completion
01 Feb 2030

What is this study about?

Bowel cancer is quite common in men. One of the main ways to treat it is with surgery, sometimes alongside radiotherapy (X-ray treatment). While these treatments are very effective at fighting the cancer, they can sometimes cause unwanted side effects, such as problems with erections. This can be very upsetting for men and can affect their quality of life.

Erection problems after bowel cancer treatment can happen for a few reasons. Surgery, even when surgeons are very careful, can sometimes affect the delicate nerves that control erections. Radiotherapy can also damage the blood vessels that are important for erections. These issues can lead to changes in the penis tissue over time, making it harder to achieve and maintain an erection.

This study is exploring whether starting Sildenafil early, shortly after treatment, can help reduce these long-term erection problems. Sildenafil works by increasing blood flow to the penis when a man is sexually aroused. By using it early, researchers hope it might help keep the tissues healthy and prevent permanent changes that lead to ongoing erection difficulties.

Key takeaways

  • This study evaluates Sildenafil (Viagra) for erection problems.
  • It's for men treated for bowel cancer with surgery and radiotherapy.
  • The goal is to prevent long-term erection difficulties.
  • You might receive Sildenafil or a dummy pill (placebo).
  • Participation involves taking medication and attending follow-up visits.

Who may be eligible?

To join this study, we are looking for men between 18 and 70 years old who are having surgery for bowel cancer that involves removing part of their rectum, after they've had radiotherapy. You must have had normal erections before your surgery, be sexually active, and have a regular sexual partner. The surgery you've had must be one where the surgeon tried to protect the nerves around the rectum.

There are also some reasons why you might not be able to join. For example, if your tumour is very large, or if you had erection problems before your surgery. If you have had prostate cancer, or if you take certain medicines like sedatives or sleeping pills, you also wouldn't be able to take part. There are medical conditions and certain medicines that mean Sildenafil isn't safe for you, so we would check for those too. Finally, if you're already in another drug trial, or if you couldn't fully understand what the study involves, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a man aged between 18 and 70?
  2. Did you have normal erections before your bowel cancer surgery?
  3. Are you sexually active and have a regular partner?
  4. Did your surgeon try to protect the nerves during your bowel cancer operation?
  5. Do you not have medical reasons that make Sildenafil unsafe for you?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to take either Sildenafil or a dummy pill (placebo) for a period after your surgery. You would need to attend regular follow-up appointments where your sexual function and general health would be assessed. This usually involves answering questionnaires. The total duration of your participation, including follow-up, would be confirmed by the study team, but the main assessment of erection problems is at 12 months after your surgery. All details about the specific tablets and the schedule of visits will be explained thoroughly by the study staff.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but it could help us understand how to improve recovery for other men in the future. Potential benefits include early access to Sildenafil if you are in that group, which might help your erectile function. Like all medicines, Sildenafil has potential side effects, which will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

  • Chu Amiens
    Verified postcode
    Amiens, France· Recruiting
  • Hopital Beauvais
    Verified postcode
    Beauvais, France· Recruiting
  • Chu Besancon
    Verified postcode
    Besançon, France· Recruiting
  • Aphp Bicetre
    Verified postcode
    Bicêtre, France· Recruiting
  • Chu Bordeaux
    Verified postcode
    Bordeaux, France· Recruiting
  • Institut Bordeaux Colorectal
    Verified postcode
    Bordeaux, France· Recruiting
  • Chu Clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Chu Lille
    Verified postcode
    Lille, France· Recruiting
  • Institut Paoli-Calmettes
    Verified postcode
    Marseille, France· Recruiting
  • Institut Du Cancer Montpellier
    Verified postcode
    Montpellier, France· Recruiting
  • Aphp St Antoine
    Verified postcode
    Paris, France· Recruiting
  • Aphp Hegp
    Verified postcode
    Paris, France· Recruiting

Common questions

What is Sildenafil?

Sildenafil is a common medicine, often known as Viagra, used to help men get and keep an erection.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps us see if the medicine really works.

Will I know if I'm taking Sildenafil or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over.

Why is this study needed?

It's to find out if early use of Sildenafil can prevent long-term erection difficulties that can happen after bowel cancer treatment.

Does this study involve new, untested drugs?

No, Sildenafil is a well-known and approved medication. This study is testing if using it early for this specific purpose is beneficial.

How to find out more

Valérie Bridoux

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Interest of Early Erectile Rehabilitation With Sildenafil Af…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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