Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study (ProstaChoc 1)

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Erectile Dysfunction

Treatments: Device: 8 bi-weekly LIESWT sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT02746094

LOCAL/2016/SD-01

Details and patient eligibility

About

The primary objective of this study is to evaluate changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores.

Full description

The secondary objectives of this study are to evaluate changes in the following elements before versus after 8 bi-weekly treatments of LIESWT:

A. EF categorical improvement.

B. Other validated measures of EF (SEP2 (question 2 of the sexual encounter profile), SEP3 (question 3 of the sexual encounter profile), GAQ (Global Assessment Question), EHS (Erection Hardness Score)), and the remaining domains of the IIEF score (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction), as well as the total IIEF score.

C. Harms/Safety: To evaluate treatment tolerance and potential adverse events.

Sex: Male

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has given his informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is a man at least 18 years old and less than 80 years old
• The patient has been in a stable, sexual relationship with only one other person for at least the past three months
• The patient is consulting for erectile dysfunction lasting for over 6 months
• The patient had a prostatectomy 18 to 60 months ago
• The patient has an erectile function domain score on the International Index of Erectile Function questionnaire between 6 and 25
• The patient has at least a natural tumescence during sexual stimulation (erection hardness score ≥ 1)
• The patient has not had phosphodiesterase type 5 inhibitor treatment for the month preceding inclusion
• The patient is available for 8 months of follow-up and agrees to participate in all study visits

Exclusion criteria

• The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, or is an adult under guardianship
• It is impossible to correctly inform the patient, or the patient refuses to sign the consent
• Complete anerection
• Untreated testosterone deficiency
• Neurological disease
• Psychiatric disease
• Anatomical malformation of the penis
• Chronic haematological pathology with significant clinical impact
• Oral or injectable antiandrogen treatment
• The patient is taking blood thinners and has an international normalized ratio > 3
• History of erectile dysfunction before the prostatectomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

The study population

Experimental group

Description:

The study population is comprised of adult men less than 80 years of age who are consulting for ED lasting for over 6 months following a prostatectomy that took place 18 to 60 months ago. The patients are currently in a stable relationship that has been going on for at least 3 months, have an IIEF-EF score between 6 and 25, and have at least a natural tumescence during sexual stimulation (EHS score ≥ 1). Intervention: 8 bi-weekly LIESWT sessions

Treatment:

Device: 8 bi-weekly LIESWT sessions