Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
Recruiting · NCT06123156 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Rouen
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSildenafil
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
14 locations listed.
- Chu Amiens - Amiens, France
- Hopital Beauvais - Beauvais, France
- Chu Besancon - Besançon, France
- Aphp Bicetre - Bicêtre, France
- Chu Bordeaux - Bordeaux, France
- Institut Bordeaux Colorectal - Bordeaux, France
- Chu Clermont-Ferrand - Clermont-Ferrand, France
- Chu Lille - Lille, France
- Institut Paoli-Calmettes - Marseille, France
- Institut Du Cancer Montpellier - Montpellier, France
- Aphp St Antoine - Paris, France
- Aphp Hegp - Paris, France
- Chu Rouen - Rouen, France
- Chu Tours - Tours, France