Low Energy Shockwave Therapy for Improving Erectile Dysfunction (Shock-ED)
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- The patient has been correctly informed about the study.
- The patient must have given his informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
- The patient is a man between 18 and 80 years of age. (≥18 years and < 80 years)
- The patient has been in a stable sexual relationship for over 3 months
- The patient is consulting for erectile dysfunction lasting for over 6 months
- IIEF-EF6 score between 6 and 25
- Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1)
- Pre-inclusion: Patient is willing to have 4 weeks of PDE5i treatment at the beginning of the trial, and then stop all treatment for an additional month.
- Pre-inclusion: The patient agrees to try to engage at least 3 sexual intercourses per month during this period
- Inclusion: Patient has completed 4 weeks of PDE5i treatment, and then stopped all treatment for an additional month.
- Patient is available for a follow up of 19 months (at time of pre-inclusion and then 17 months at time of inclusion)
Exclusion Criteria:
- The patient is participating in another interventional study
- Within the past three months, the patient has participated in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Complete anerection
- History of pelvic cancer surgery (radical prostatectomy, cystectomy, abdominoperineal resection of the rectum)
- Untreated testosterone deficiency
- Neurological disease affecting the central nervous system
- Untreated psychiatric disease, or psychiatric disease that may compromise study participation
- Anatomical malformation of the penis considered by the investigator as being able to prevent vaginal penetration
- Chronic haematological pathology associated with risk of haemorrhage
- Oral or injectable antiandrogen treatment
- The patient is taking blood thinners AND/OR has an International Normalized Ratio >3
- Known allergy to treatments used in the study (e.g. Cialis, gel)
Exclusion criteria: The patient has contraindications for Cialis as mentioned in the SPC, re-given here :
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC.
- In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated. (see section 4.5 of the SPC).
- CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
- The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:
- patients with myocardial infarction within the last 90 days,
- patients with unstable angina or angina occurring during sexual intercourse,
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,
- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled
- uncontrolled hypertension,
- patients with a stroke within the last 6 months.
- CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4 of the SPC).
Sites / Locations
- CHU de Bordeax - Hôpital Pellegrin
- APHP - Hôpital Raymond-Poincaré
- Clinique Beau Soleil
- CHRU de Nîmes - Hôpital Universitaire Carémeau
- CHU de Lyon - Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
LIESWT arm
Sham arm
Patients randomized to this arm will have two sequences of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT). Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.
Patients randomized to this arm will have one sequence of sham Low-Intensity Extracorporeal Shock Wave Therapy and then three months later one sequence of Low-Intensity Extracorporeal Shock Wave Therapy. Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly sham LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.