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

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ClinicalTrials.gov Identifier: NCT03530540
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Lars Lund,MD, 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.


Condition or disease Intervention/treatment Phase
Peyronie Disease Device: low-intensity extracorporeal shockwave therapy Device: Placebo LI-ESWT Device: Penile pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

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: Placebo LI-ESWT
Placebo shockwaves

Device: Penile pump
both groups will be treated with a penile pump




Primary Outcome Measures :
  1. Change in penile curvature [ Time Frame: 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 :
  1. Change in pain score using the Visual Analogue Scale (VAS) [ Time Frame: 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.

  2. Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5). [ Time Frame: 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.

  3. Change in Peyronies disease questionnaire score [ Time Frame: Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months. ]
    Questionnaire to evaluate the psychological/physical consequences of peyronies disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530540


Locations
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Denmark
Odense university hospital Recruiting
Odense, Denmark, 5000
Contact: Lars Lund, Professor    45 5140 8982    Lars.Lund@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Lars Lund,MD, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03530540     History of Changes
Other Study ID Numbers: 20170201
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases