Ireland
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Recruiting Phase 3

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

NCT06123156 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-09-25
Last updated
2026-05-12

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Sildenafil →Placebo

Sildenafil: Sildénafil during 10 months (50mg daily), start 30 days after surgery

Placebo: 1 platelet during 10 months (daily), start 30 days after surgery

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * T4 tumor or tumor requiring extended surgery * Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22. * History of prostate cancer * Sleep disorders, patients taking sedatives/hypnotics * Contraindication to SILDENAFIL EG 50 mg, film-coated tablet * Contraindication to placebo * Patients already treated with PDE5 inhibitors * 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. * 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. * Person participating in another drug trial.

Primary outcome measure(s)

  • the patient's response — 12 months postoperatively
    A patient is defined as a responder by a score of at least 22 for the erectile function domain of the International Index of Erectile Function (IIEF), comprising the six IIEF questions relating to erection (Q1-Q5 and Q15).

Trial sites (14)

FacilityCityRegionStatus
Chu Amiens Amiens France Recruiting
Hopital Beauvais Beauvais France Recruiting
Chu Besancon Besançon France Recruiting
Aphp Bicetre Bicêtre France Recruiting
Chu Bordeaux Bordeaux France Recruiting
Institut Bordeaux Colorectal Bordeaux France Recruiting
Chu Clermont-Ferrand Clermont-Ferrand France Recruiting
Chu Lille Lille France Recruiting
Institut Paoli-Calmettes Marseille France Recruiting
Institut Du Cancer Montpellier Montpellier France Recruiting
Aphp St Antoine Paris France Recruiting
Aphp Hegp Paris France Recruiting
Chu Rouen Rouen France Recruiting
Chu Tours Tours France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06123156 on ClinicalTrials.gov ↗ ← All trials in France