Interest of early erectile rehabilitation with Sildenafil after radiotherapy and proctectomy for rectal cancer

Interest of early erectile rehabilitation with Sildenafil after radiotherapy and proctectomy for rectal cancer: Randomized controlled trial - RECTIL - RECTIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002682-34-FR

Enrollment

188

Registered

2023-01-30

Start date

2023-04-20

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men treated with proctectomy and neoadjuvant radiation therapy for rectal cancer MedDRA version: 20.0 Level: LLT Classification code 10007464 Term: Carcinoma rectum System Organ Class: 100000004864 MedDRA version: 20.0 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 22.1 Level: LLT Classification code 10025503 Term: Male erectile disorder System Organ Class: 10038604 - Reproductive system

Interventions

Trade Name: SILDENAFIL EG 50 mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Men aged 18 to 70 years - 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 - Patient with normal preoperative erectile function (defined as a combined IIEF erectile function domain score of at least 22) - Sexually active patient without treatment for erectile function prior to surgery - Presence of a stable sexual partner (male or female) - Adult who has read and understood the information letter and signed the consent form Membership in a social security plan Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: T4 tumor or requiring an enlarged surgery History of prostate cancer Sleep disorder, patients taking sedatives/hypnotics 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 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 - Hypersensitivity to the active substance or to one of the excipients - Allergy to peanuts or soy Contraindication to Placebo - allergy to one of its components (polyethylene glycol 3350, starch) - treatment with polyethylene glycol (macrogol: forlax, transipeg) Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship 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 from giving informed consent Individual participating in another drug trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate the efficacy of erectile rehabilitation with Sildenafil after neoadjuvant radiotherapy and proctectomy in the prevention of long-term erectile dysfunction at 12 months post-operatively;Secondary Objective: To evaluate erectile function, sexual function, quality of life, digestive function and anal continence at D30 of surgery - Evaluate the effectiveness of Sildenafil on erectile function at 3, 6 and 9 months post-surgery - Evaluate the effectiveness of Sildenafil on sexual function at 3, 6, 9 and 12 months post-surgery - To evaluate the efficacy of erectile rehabilitation with Sildenafil on the quality of life of patients at 3, 6, 9 and 12 months post-operatively - To evaluate the efficacy of Sildenafil on digestive function and fecal incontinence at 3, 6, 9 and 12 months post-operatively - To evaluate the efficacy of Sildenafil on the number of patients with spontaneous erection at 3, 6, 9 and 12 months post-operatively - To evaluate if the association of psychological support with erectile rehabilitation with Sildenafil improves sexual function. - To evaluate compliance with the treatment - To evaluate the frequency and severity of adverse events;Primary end point(s): The primary endpoint is 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) ;Timepoint(s) of evaluation of this end point: 12 months after surgery	—

Measure

Time frame

Main Objective: The main objective is to evaluate the efficacy of erectile rehabilitation with Sildenafil after neoadjuvant radiotherapy and proctectomy in the prevention of long-term erectile dysfunction at 12 months post-operatively;Secondary Objective: To evaluate erectile function, sexual function, quality of life, digestive function and anal continence at D30 of surgery - Evaluate the effectiveness of Sildenafil on erectile function at 3, 6 and 9 months post-surgery - Evaluate the effectiveness of Sildenafil on sexual function at 3, 6, 9 and 12 months post-surgery - To evaluate the efficacy of erectile rehabilitation with Sildenafil on the quality of life of patients at 3, 6, 9 and 12 months post-operatively - To evaluate the efficacy of Sildenafil on digestive function and fecal incontinence at 3, 6, 9 and 12 months post-operatively - To evaluate the efficacy of Sildenafil on the number of patients with spontaneous erection at 3, 6, 9 and 12 months post-operatively - To evaluate if the association of psychological support with erectile rehabilitation with Sildenafil improves sexual function. - To evaluate compliance with the treatment - To evaluate the frequency and severity of adverse events;Primary end point(s): The primary endpoint is 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) ;Timepoint(s) of evaluation of this end point: 12 months after surgery

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Secondary

Measure	Time frame
Secondary end point(s): - IIEF Erectile Function Domain Score, which includes the six IIEF questions related to erection (Q1-Q5 and Q15) measured at D0, M1, M3, M6, M9 and M12 - International Index of Erectile Function (IIEF) global score measured at D0, M1, M3, M6, M9 and M12 - Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at D0, M1, M3, M6, M9 and M12 - LARS score measured at D0, M1, M3, M6, M9 and M12 - Fecal Continence Score (Wexner score) measured at D0, M1, M3, M6, M9 and M12 - Number of patients with spontaneous erections on treatment at M3, M6, M9 and without treatment at M1, and M12 - The number of patients with or without regular psychological follow-up. A patient is defined as having a regular follow-up if he goes once or twice a month to see a psychologist and/or a psychiatrist - Number of tablets not used during the study. The patient will be considered as non-compliant if the tablet intake over the whole 10 months of treatment is <80%. - The number of AEs and SAEs in each group at M1, M3, M6, M9 and M12 ;Timepoint(s) of evaluation of this end point: D0, M1, M3, M6, M9 and M12	—

Measure

Time frame

Secondary end point(s): - IIEF Erectile Function Domain Score, which includes the six IIEF questions related to erection (Q1-Q5 and Q15) measured at D0, M1, M3, M6, M9 and M12 - International Index of Erectile Function (IIEF) global score measured at D0, M1, M3, M6, M9 and M12 - Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at D0, M1, M3, M6, M9 and M12 - LARS score measured at D0, M1, M3, M6, M9 and M12 - Fecal Continence Score (Wexner score) measured at D0, M1, M3, M6, M9 and M12 - Number of patients with spontaneous erections on treatment at M3, M6, M9 and without treatment at M1, and M12 - The number of patients with or without regular psychological follow-up. A patient is defined as having a regular follow-up if he goes once or twice a month to see a psychologist and/or a psychiatrist - Number of tablets not used during the study. The patient will be considered as non-compliant if the tablet intake over the whole 10 months of treatment is <80%. - The number of AEs and SAEs in each group at M1, M3, M6, M9 and M12 ;Timepoint(s) of evaluation of this end point: D0, M1, M3, M6, M9 and M12

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Countries

France

Contacts

Public ContactJulie RONDEAUX

CHU de Rouen

secretariat.DRC@chu-rouen.fr+33232888265

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026