NCT02746094

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

April 13, 2016

Last Update Submit

June 16, 2017

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

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

    rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

Secondary Outcomes (35)

  • 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.

    -8 to 0 weeks versus 0 to 8 weeks

  • 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.

    -8 to 0 weeks versus 0 to 16 weeks

  • 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 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.

    -8 to 0 weeks versus 0 to 8 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.

    -8 to 0 weeks versus 0 to 16 weeks

  • +30 more secondary outcomes

Study Arms (1)

The study population

EXPERIMENTAL

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

Device: 8 bi-weekly LIESWT sessions

Interventions

8 bi-weekly LIESWT sessionsDEVICE

LIESWT = Low-Intensity Extracorporeal Shock Wave Therapy The treatment protocol consists of eight bi-weekly treatment sessions (weeks 0 ot 4). During each session 3600 shocks at 0.09 mJ/mm are applied. Shocks are applied to the penis shaft at the right corpus cavernosum and the left corpus cavernosum, and at the crura at the right crus and the left crus. 900 shocks are administered to each area. The treatment areas are the same for each session, so that at the end of the full treatment (8 sessions) each area will have received 7200 shocks at 0.09 mJ/mm. In general, the patient is placed on an examination table. A series of focused shockwaves produced by the electromagnetic transducer are coupled to a patient's penile shaft and crura and are made to converge along the penis/crura volume. The operator controls treatment parameters including shockwave intensity and shockwave rate. mJ = millijoule.

Also known as: RENOVA device
The study population

Eligibility Criteria

Age18 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 is available for 8 months of follow-up and agrees to participate in all study visits

You may not qualify if:

  • The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 21855209BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Stéphane Droupy, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 21, 2016

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

FR(1)