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

NCT02746094 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-06-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

8 bi-weekly LIESWT sessions

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.

Sponsors & Collaborators

  • Direx Systems GmbH

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02746094 on ClinicalTrials.gov