Low Energy Shockwave Therapy for Improving Erectile Dysfunction

• Status: Completed
• Trial end date: 2020-06-22
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment. The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).