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

Odense University Hospital

Status: Unknown

Conditions: Peyronie Disease

Treatments: Device: Penile pump; Device: low-intensity extracorporeal shockwave therapy; Device: Placebo LI-ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT03530540

20170201

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Active shockwaves

Treatment:

Device: low-intensity extracorporeal shockwave therapy

Device: Penile pump

Placebo

Placebo Comparator group

Description:

Placebo shockwaves

Treatment:

Device: Placebo LI-ESWT

Device: Penile pump