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

Centre Hospitalier Universitaire de Nīmes1 site in 1 countryApril 2017

ConditionsErectile Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Centre Hospitalier Universitaire de Nīmes
Locations: 1
Primary Endpoint: The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 2017

End Date

April 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).

Time Frame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

IIEF-EF = the erectile function domain of the International Index of Erectile Function

Secondary Outcomes

The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.(0 to 8 weeks versus 8 to 16 weeks)
The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.(0 to 8 weeks versus 8 to 16 weeks)
The presence/absence any other complications that might occur (almost none are cited in the literature)(Week 16)
The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.(0 to 8 weeks versus 8 to 16 weeks)
The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.(0 to 8 weeks versus 8 to 16 weeks)
The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)
Visual analog scale for pain during treatment (score from 0 to 10)(Week 4, Thursday or Friday)
The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)(rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks)