NCT06123156RecruitingPhase 3
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 26 Oct 2023
- Start date
- 25 Sept 2025
- Primary completion date
- Feb 2030
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Colorectal cancer
- NCT number
- NCT06123156
- EU CT number
- 2024-515431-30-00
- EudraCT number
- 2020-002682-34
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 188
- From 25 Sept 2025 to the primary completion date, Feb 2030
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- T4 tumor or tumor requiring extended surgery
- Patients already treated with PDE5 inhibitors
- Person participating in another drug trial.
Other illness
- History of prostate cancer
- Sleep disorders, patients taking sedatives/hypnotics
- Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent.
Other
- Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22.
- Contraindication to SILDENAFIL EG 50 mg, film-coated tablet
- Contraindication to placebo
- Patients suffering from SARS COV 2\*
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.
Who the study is looking for
- Men aged 18 to 70
- Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22).
- Nerve-conserving surgery
- Sexually active patient without treatment for erectile function prior to surgery
- Presence of a regular sexual partner (male or female)
- Adult having read and understood the information letter and signed the consent form
- Membership of a social security scheme
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Centre Hospitalier Simone Veil De Beauvais Coordinator of this site? Confirm its status | Beauvais | France | Recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Bordeaux Colorectal Institute Academy Coordinator of this site? Confirm its status | Le Bouscat | France | Recruiting |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin Bicetre Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Recruiting |
| CHU Bordeaux Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.