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Interest of early erectile rehabilitation with Sildenafil after proctectomy for rectal cancer : Randomized controlled trial (RECTIL)
EU CTIS ID: 2024-515431-30-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 30 days ago (+/- 7 days) and 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
You likely can't join if
- T4 tumor or requiring an enlarged surgery
- History of prostate cancer
- 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
- Sleep disorder, patients taking sedatives/hypnotics
- Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22
- Contraindication to Placebo : Allergy to one of its components (polyethylene glycol 3350, starch) Treatment with polyethylene glycol (macrogol: forlax, transipeg)
See the full eligibility criteria
Who can join
- 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 30 days ago (+/- 7 days) and 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
- Conservative nerve surgery
What rules you out
- T4 tumor or requiring an enlarged surgery
- History of prostate cancer
- 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
- Sleep disorder, patients taking sedatives/hypnotics
- Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22
- Contraindication to Placebo : Allergy to one of its components (polyethylene glycol 3350, starch) Treatment with polyethylene glycol (macrogol: forlax, transipeg)
- Patients already treated with PDE5 inhibitors
- 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".
- Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub-guardianship or curatorship
- 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.
- Person participating in another drug trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.