Low Energy Shockwave Therapy for Improving Erectile Dysfunction

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.

Conditions

• Erectile Dysfunction

Interventions

OTHER

Pre-inclusion questionnaires

(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

DRUG

1 month of PDE5i treatment

5 mg Tadalafil per day for 1 month

OTHER

PDE5i follow-up questionnaires

(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

OTHER

Inclusion questionnaires

(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.

DEVICE

4 weekly LIESWT (Wave 1) with the RENOVA device

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.

DEVICE

4 weekly sham LIESWT (Wave 1) with the RENOVA device

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.

OTHER

Follow-up questionnaires 1 month after Wave 1

(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.

OTHER

Follow-up questionnaires 3 months after Wave 1

(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.

DEVICE

8 bi-weekly LIESWT (Wave 2) with the RENOVA device

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.

OTHER

Follow-up questionnaires 1 month after Wave 2

(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.

OTHER

Questionnaires via postal mail

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.

OTHER

Final follow-up questionnaires 12 months after Wave 2

(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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes

  lead OTHER

Principal Investigators

• Stéphane Droupy, MD, PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-01

Primary Completion

2018-02-21

Completion

2020-06-22

Countries

• France

Study Locations