Interest of early erectile rehabilitation with Sildenafil after proctectomy for rectal cancer : Randomized controlled trial (RECTIL)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

14 Aug 2025 → ongoing

Decision date (initial)

2024-09-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515431-30-00

EudraCT number

2020-002682-34

ClinicalTrials.gov

NCT06123156

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The main objective is to evaluate the efficacy of erectile rehabilitation with Sildenafil after proctectomy in the prevention of long-term erectile dysfunction at 12 months post-operatively

Secondary objectives 9

1. Evaluate erectile function, sexual function, quality of life, digestive function and anal continence at surgery and at D30 (+/- 7 days) of surgery (J0)
2. Evaluate the effectiveness of Sildenafil on erectile function at 3, 6 and 9 months post-surgery
3. Evaluate the effectiveness of Sildenafil on sexual function at 3, 6, 9 and 12 months post-surgery
4. Evaluate the efficacy of erectile rehabilitation with Sildenafil on the quality of life of patients at 3, 6, 9 and 12 months post-surgery
5. Evaluate the efficacy of Sildenafil on digestive function and fecal incontinence at 3, 6, 9 and 12 months post-surgery
6. Evaluate the efficacy of erectile rehabilitation with Sildenafil on the number of patients with a spontaneous erection at 3, 6, 9 under treatment and without treatment at D0 and 12 months post-surgery.
7. Evaluate if the association of psychological support with erectile rehabilitation with Sildenafil improves sexual function
8. Evaluate compliance with the treatment
9. Evaluate the frequency and severity of adverse events

Conditions and MedDRA coding

Men treated with proctectomy for rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Men aged 18 to 70 years
2. 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)
3. Sexually active patient without treatment for erectile function prior to surgery
4. Presence of a stable sexual partner (male or female)
5. Adult who has read and understood the information letter and signed the consent form
6. Membership in a social security plan
7. Conservative nerve surgery

Exclusion criteria 11

1. T4 tumor or requiring an enlarged surgery
2. Sleep disorder, patients taking sedatives/hypnotics
3. Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22
4. Contraindication to Placebo : Allergy to one of its components (polyethylene glycol 3350, starch) Treatment with polyethylene glycol (macrogol: forlax, transipeg)
5. Patients already treated with PDE5 inhibitors
6. 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".
7. Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub-guardianship or curatorship
8. 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.
9. Person participating in another drug trial
10. History of prostate cancer
11. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 9

1. 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
2. International Index of Erectile Function global score measured at surgery, D0, M3, M6, M9 and M12 postoperative
3. Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at surgery, D0, M3, M6, M9 and M12 postoperative
4. LARS score measured at surgery, D0, M3, M6, M9 and M12 postoperative
5. Fecal Continence Score (Wexner score) measured at surgery, D0, M3, M6, M9 and M12 postoperative
6. The number of patients presenting spontaneous erections under treatment at M3, M6, M9 postoperative and without treatment at D0, and M12 postoperative.
7. 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
8. 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%.
9. The number of AEs and SAEs in each group at D0, M3, M6, M9 and M12 postoperative

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications