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

Peyronie Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530540
• Other study ID #: 20170201
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie Disease

Intervention

Device:
• low-intensity extracorporeal shockwave therapy
Active shockwaves
• Placebo LI-ESWT
Placebo shockwaves
• Penile pump
both groups will be treated with a penile pump

Locations

Country	Name	City	State
Denmark	Odense university hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.