Clinical trial NCT02746094: Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study
Official title: Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Direx Systems GmbH
First posted: 2016-04-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 8 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 16 weeks
measure: 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.
timeFrame: 0 to 8 weeks versus 8 to 16 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 8 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 16 weeks
measure: 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.
timeFrame: 0 to 8 weeks versus 8 to 16 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 8 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 16 weeks
measure: 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.
timeFrame: 0 to 8 weeks versus 8 to 16 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 8 weeks
measure: 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.
timeFrame: -8 to 0 weeks versus 0 to 16 weeks
measure: 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.
timeFrame: 0 to 8 weeks versus 8 to 16 weeks
measure: The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
measure: The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
timeFrame: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 1, Monday or Tuesday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 1, Thursday or Friday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 2, Monday or Tuesday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 2, Thursday or Friday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 3, Monday or Tuesday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 3, Thursday or Friday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 4, Monday or Tuesday
measure: Visual analog scale for pain during treatment (score from 0 to 10)
timeFrame: Week 4, Thursday or Friday
measure: The presence/absence any other complications that might occur (almost none are cited in the literature)
timeFrame: Week 16
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Droupy, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.