NCT02304679

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

November 20, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

November 20, 2014

Last Update Submit

August 3, 2020

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in IIEF-EF score

    Month 0 versus Month 4

Secondary Outcomes (58)

  • % patients with improvement

    Month 0 versus Month 4

  • % patients with improvement

    Month -2 versus Month -1

  • % patients with improvement

    Month 0 versus Month 2

  • % patients with improvement

    Month 0 versus Month 8

  • % patients with improvement

    Month 4 versus Month 8

  • +53 more secondary outcomes

Study Arms (2)

LIESWT arm

EXPERIMENTAL

Patients randomized to this arm will have two sequences of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT). Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.

Other: Pre-inclusion questionnairesDrug: 1 month of PDE5i treatmentOther: PDE5i follow-up questionnairesOther: Inclusion questionnairesDevice: 4 weekly LIESWT (Wave 1) with the RENOVA deviceOther: Follow-up questionnaires 1 month after Wave 1Other: Follow-up questionnaires 3 months after Wave 1Device: 8 bi-weekly LIESWT (Wave 2) with the RENOVA deviceOther: Follow-up questionnaires 1 month after Wave 2Other: Questionnaires via postal mailOther: Final follow-up questionnaires 12 months after Wave 2

Sham arm

PLACEBO COMPARATOR

Patients randomized to this arm will have one sequence of sham Low-Intensity Extracorporeal Shock Wave Therapy and then three months later one sequence of Low-Intensity Extracorporeal Shock Wave Therapy. Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly sham LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.

Other: Pre-inclusion questionnairesDrug: 1 month of PDE5i treatmentOther: PDE5i follow-up questionnairesOther: Inclusion questionnairesDevice: 4 weekly sham LIESWT (Wave 1) with the RENOVA deviceOther: Follow-up questionnaires 1 month after Wave 1Other: Follow-up questionnaires 3 months after Wave 1Device: 8 bi-weekly LIESWT (Wave 2) with the RENOVA deviceOther: Follow-up questionnaires 1 month after Wave 2Other: Questionnaires via postal mailOther: Final follow-up questionnaires 12 months after Wave 2

Interventions

Pre-inclusion questionnairesOTHER

(Month -2) During this visit, the investigator will: * Validate the patient's inclusion and exclusion criteria; * Obtain informed consent from the patient; * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality. * Prescribe 1 month of PDE5i treatment. * The next visit will be scheduled

LIESWT armSham arm
1 month of PDE5i treatmentDRUG

5 mg Tadalafil per day for 1 month

LIESWT armSham arm
PDE5i follow-up questionnairesOTHER

(Month -1) During this visit the investigator will: * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events. * Remind the patient that over the next 4 weeks he is not to take any treatments for his condition (wash-out period). * The next visit will be scheduled

LIESWT armSham arm
Inclusion questionnairesOTHER

(Day 0) During this visit the investigator will: * Verify inclusion and exclusion criteria, and proceed with final inclusion * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events. * Randomize the patient at the end of the visit * The patient will go home with a calendar specifying the time and place of the various visits. The patient should have four weekly LIESWT or sham sessions within the next month. The first session may take place the same day and immediately after the present visit.

LIESWT armSham arm
4 weekly LIESWT (Wave 1) with the RENOVA deviceDEVICE

Following final inclusion, patients will have weekly LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

LIESWT arm
4 weekly sham LIESWT (Wave 1) with the RENOVA deviceDEVICE

Following final inclusion, patients will have weekly sham LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

Sham arm
Follow-up questionnaires 1 month after Wave 1OTHER

(Month 2) During this visit the investigator will: * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events.

LIESWT armSham arm
Follow-up questionnaires 3 months after Wave 1OTHER

(Month 4) During this visit the investigator will: * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events. * The patient should have four weekly LIESWT sessions within the next month. The first session may take place the same day and immediately after the present visit.

LIESWT armSham arm
8 bi-weekly LIESWT (Wave 2) with the RENOVA deviceDEVICE

During the 5th month following final inclusion, all patients will have bi-weekly LIESWT sessions. These will occur twice per week for four consecutive weeks. Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

LIESWT armSham arm
Follow-up questionnaires 1 month after Wave 2OTHER

(Month 6) During this visit the investigator will: * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events.

LIESWT armSham arm
Questionnaires via postal mailOTHER

Eight, 11, and 14 months after final inclusion, corresponding to 3, 6 and 9 months following Wave 2, the IIEF, SEP2, SEP3, GAQ and EHS questionnaires will be sent to patients via postal mail.

LIESWT armSham arm
Final follow-up questionnaires 12 months after Wave 2OTHER

(Month 17) During this visit the investigator will: * Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope. * Perform a clinical exam; particular attention is given to the recording of complications / adverse events.

LIESWT armSham arm

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • The patient is participating in another interventional study
  • Within the past three months, the patient has participated in another interventional 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Bordeax - Hôpital Pellegrin

Bordeaux, 33000, France

Location

APHP - Hôpital Raymond-Poincaré

Garches, 92380, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 2, 2014

Study Start

July 1, 2015

Primary Completion

February 21, 2018

Study Completion

June 22, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations

FR(5)