SILDENAFIL for Rectal cancer | Erectile dysfunction (post-proctectomy)

Inclusion criteria

• {"criterion_text":"- Men aged 18 to 70 years\n- Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis 30 days ago (+/- 7 days) and with normal preoperative erectile function (defined as a combined IIEF erectile function domain score of at least 22)\n- Sexually active patient without treatment for erectile function prior to surgery\n- Presence of a stable sexual partner (male or female)\n- Adult who has read and understood the information letter and signed the consent form\n- Membership in a social security plan\n- Conservative nerve surgery"}

Exclusion criteria

• {"criterion_text":"- T4 tumor or requiring an enlarged surgery\n- History of prostate cancer\n- Contraindication to SILDENAFIL EG 50 mg, film-coated tablet: - Cardiovascular disease (history of heart failure, myocardial infarction, angina, arrhythmia, aortic stenosis, or hypertrophic obstructive cardiomyopathy) except controlled hypertension - Recent history of stroke - Hypotension (blood pressure < 90/50 mmHg) - Severe hepatic insufficiency - Severe renal insufficiency (creatinine clearance less than 30 ml/min) - Uncontrolled diabetes (hemoglobin A1C >12%) - Bleeding disorders or active peptic ulcer - Anatomical malformation of the penis (angulation, fibrosis of the corpora cavernosa or Peyronie's disease) - Patients with conditions that may predispose them to priapism (such as sickle cell disease, multiple myeloma or leukemia) - Patients with loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NOIAN) - Known degenerative hereditary retinal disorders such as retinitis pigmentosa, - Drug combinations contraindicating sildenafil (o cytochrome P450 inhibitors (ritonavir), CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin, cimetidine, saquinavir, ritonavir, saquinavir and grapefruit juice) o nitric oxide donors (such as the amyl nitrite sold over the counter in sex shops (\"poppers\") or nitro derivatives in any form (trinitrine or isosorbide mono or dinitrate, sodium nitroprusside; linsidomine, molsidomine, nicorandil). Such combinations are dangerous for life. - alpha-blockers (prazosin, urapidil) - guanylate cyclase stimulators, such as riociguat) - Hypersensitivity to the active substance or to one of the excipients - Allergy to peanuts or soy\n- Sleep disorder, patients taking sedatives/hypnotics\n- Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22\n- Contraindication to Placebo : Allergy to one of its components (polyethylene glycol 3350, starch) Treatment with polyethylene glycol (macrogol: forlax, transipeg)\n- Patients already treated with PDE5 inhibitors\n- Patients with SARS COV 2* * In accordance with the general measures required to deal with the Covid-19 epidemic, as set out in an order issued by the Minister of Solidarity and Health, the diagnostic test(s) used to detect SARS-CoV-2 must be included in the list published on the website of the Ministry of Solidarity and Health, available at the following address: https://covid-19.sante.gouv.fr/tests\".\n- Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub-guardianship or curatorship\n- History of psychological or sensory illness or abnormality that could affect the subject's ability to understand the conditions required for participation in the protocol or to give informed consent.\n- Person participating in another drug trial"}

Primary endpoints

• {"endpoint_text":"- Patient response at 12 months post-operatively. A patient is defined as a responder by a score of at least 22 on the erectile function domain of the International Index of Erectile Function (IIEF), which includes the six questions of the IIEF related to erection (Q1-Q5 and Q15)","definition_or_measurement_approach":"Responder defined as IIEF erectile function domain score >= 22 (six IIEF questions Q1-Q5 and Q15) measured at 12 months post-operatively."}

Secondary endpoints

• {"endpoint_text":"- IIEF erectile function domain score combining the six IIEF questions related to erection (Q1-Q5 and Q15) measured at surgery, D0, M3, M6 and M9 postoperative\n- International Index of Erectile Function global score measured at surgery, D0, M3, M6, M9 and M12 postoperative\n- Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at surgery, D0, M3, M6, M9 and M12 postoperative\n- LARS score measured at surgery, D0, M3, M6, M9 and M12 postoperative\n- Fecal Continence Score (Wexner score) measured at surgery, D0, M3, M6, M9 and M12 postoperative\n- The number of patients presenting spontaneous erections under treatment at M3, M6, M9 postoperative and without treatment at D0, and M12 postoperative.\n- The number of patients with or without regular psychological followup. A patient is defined as having regular follow-up if he visits a psychologist and/or psychiatrist once or twice a month\n- Number of unused tablets during the study. The patient will be considered as non-compliant if tablet intake over the entire 10 months of treatment is < 80%.\n- The number of AEs and SAEs in each group at D0, M3, M6, M9 and M12 postoperative","definition_or_measurement_approach":"IIEF erectile function domain (Q1-Q5 & Q15) measured at specified timepoints (surgery, D0, M3, M6, M9); IIEF global score at surgery, D0, M3, M6, M9, M12; QoL by EORTC QLQ-C30 and QLQ-CR29 at listed timepoints; LARS and Wexner scores at listed timepoints; counts of spontaneous erections at specified visits; psychological follow-up defined as visiting a psychologist/psychiatrist once or twice a month; compliance assessed by count of unused tablets and adherence <80% over 10 months considered non-compliant; safety assessed by number of AEs and SAEs at listed visits."}

France

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

484

Number Of Sites

14

Number Of Participants

188

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France