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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Simone Veil De Beauvais	Beauvais	France
Hopital Beaujon	Clichy	France
Ipfrzhbd Rbabvdur Da Cjyklx Dy Mkhlqhrkget	Montpellier	France
Bcwnkcuc Cuejsybszz Incttwdwm Aargyme	Le Bouscat	France
Buwbrowo Uwjkbeqzjd Hptoaqjz Cgxure	Besançon	France
Cdmlvr Hjzwlkpkjxv Rxqtenkz Uexsjurxcykjy Dn Telgt	Tours	France
Iitwnasg Pvtkoslboauzxjs Cjvief Crxbsr	Marseille	France
Cxw Ktvidib Bjgyrqg	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2025

Trial locations

Investigated drugs:

Sildenafil

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.

Investigated diseases:

Rectal cancer

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 ID:

2024-515431-30-00

Protocol code:

2019/0398/HP

NCT ID:

NCT06123156

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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