NCT02746094

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Male
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-04-21
• Last updated: 2017-06-20

Locations

1 site across 1 country: France