Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.
NCT ID: NCT03530540
Last Updated: 2019-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-03-13
2020-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Active shockwaves
low-intensity extracorporeal shockwave therapy
Active shockwaves
Penile pump
both groups will be treated with a penile pump
Placebo
Placebo shockwaves
Placebo LI-ESWT
Placebo shockwaves
Penile pump
both groups will be treated with a penile pump
Interventions
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low-intensity extracorporeal shockwave therapy
Active shockwaves
Placebo LI-ESWT
Placebo shockwaves
Penile pump
both groups will be treated with a penile pump
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous surgery for PD
* Patients undergoing other interventions for PD
18 Years
MALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Lars Lund,MD
Professor
Locations
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Odense university hospital
Odense, , Denmark
Countries
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Facility Contacts
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Other Identifiers
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20170201
Identifier Type: -
Identifier Source: org_study_id
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