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

Not Applicable

• Conditions: Peyronie Disease
• Interventions: Device: Placebo LI-ESWT; Device: low-intensity extracorporeal shockwave therapy; Device: Penile pump

• Registration Number: NCT03530540
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo LI-ESWT	Placebo shockwaves
Intervention	low-intensity extracorporeal shockwave therapy	Active shockwaves
Placebo	Penile pump	Placebo shockwaves
Intervention	Penile pump	Active shockwaves

Primary Outcome Measures

Name	Time	Method
Change in penile curvature	penile curve will be assessed at baseline, and 1,3 and 6 months.	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.

Secondary Outcome Measures

Name	Time	Method
Change in pain score using the Visual Analogue Scale (VAS)	VAS will be assessed at baseline, and 1,3 and 6 months.	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.
Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).	IIEF-5 will be assessed at baseline, and 1,3 and 6 months.	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.
Change in Peyronies disease questionnaire score	Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.	Questionnaire to evaluate the psychological/physical consequences of peyronies disease.

Trial Locations

Locations (1)

Odense university hospital; 🇩🇰 Odense, Denmark