Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.

A Prospective Randomized Double Blinded Placebo Controlled Clinical Trial Evaluating the Combined Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) and Vacuum Erectile Device Combined With Manipulation Exercises on Peyronies Disease.

Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.

Primary Outcome

• Peyronie's Disease Questionnaire (PDQ)
• Visual Analogue Scale score (VAS)
• International Index of Erectile Function 5 (IEFF-5)
• Penile curve measurements (gold standard) on pictures before and after treatment
• Plaque size

Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.

A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.

All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.

Study Overview

• Status: Unknown
• Conditions: Peyronie Disease
• Intervention / Treatment: Device: low-intensity extracorporeal shockwave therapy; Device: Penile pump; Device: Placebo LI-ESWT

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Lars Lund, Professor; Phone Number: 45 5140 8982; Email: Lars.Lund@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• PD for more than 6 months
• Penile curve greater than 30 degrees and less than 90 degrees
• Age 18-80
• No previous penile surgery
• Informed consent
• Able to speak and understand Danish

Exclusion Criteria:

• Penile curve greater than 90 degrees
• Previous surgery for PD
• Patients undergoing other interventions for PD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Active shockwaves	Device: low-intensity extracorporeal shockwave therapy; Active shockwaves; Device: Penile pump; both groups will be treated with a penile pump
Placebo Comparator: Placebo; Placebo shockwaves	Device: Penile pump; both groups will be treated with a penile pump; Device: Placebo LI-ESWT; Placebo shockwaves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in penile curvature	Change in penile curvature from baseline to follow-up at 1,3 and 6 months. Penile curvature is measured on pictures submitted by the patient.	penile curve will be assessed at baseline, and 1,3 and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain score using the Visual Analogue Scale (VAS)	VAS is a subjective pain score ranging from 0-10 whereas 0 means no pain, and 10 being excruciating pain. Patients are asked to rank their average pain for the last 24 hours.	VAS will be assessed at baseline, and 1,3 and 6 months.
Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).	Erectile function is estimated using the IIEF-5 which is a 5 item questionnaire. Based on the patients answers a final score is merged. The definition of erectile dysfunction(ED) is; 5-7 (severe), 8-11(moderate), 12-16(mild-moderate), 17-21(mild) and 22-25 no ED.	IIEF-5 will be assessed at baseline, and 1,3 and 6 months.
Change in Peyronies disease questionnaire score	Questionnaire to evaluate the psychological/physical consequences of peyronies disease.	Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: 20170201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No