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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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens - Picardie
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
Centre Hospitalier Simone Veil De Beauvais
Coordinator of this site? Confirm its status
BeauvaisFranceRecruiting
CHU Besançon
Coordinator of this site? Confirm its status
BesançonFranceRecruiting
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
Bordeaux Colorectal Institute Academy
Coordinator of this site? Confirm its status
Le BouscatFranceRecruiting
Bicetre Hospital
Coordinator of this site? Confirm its status
Le Kremlin Bicetre CedexFranceRecruiting
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceRecruiting
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Institut Regional Du Cancer De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceRecruiting
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Saint Antoine
Coordinator of this site? Confirm its status
Paris Cedex 12FranceRecruiting
CHU Bordeaux Haut-Leveque
Coordinator of this site? Confirm its status
PessacFranceRecruiting
Centre Hospitalier Universitaire Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Tours Cedex 9FranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.