NCT03530540

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

May 7, 2018

Last Update Submit

March 13, 2019

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in pain score using the Visual Analogue Scale (VAS)

    VAS will be assessed at baseline, and 1,3 and 6 months.

  • 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.

  • Change in Peyronies disease questionnaire score

    Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.

Study Arms (2)

Intervention

EXPERIMENTAL

Active shockwaves

Device: low-intensity extracorporeal shockwave therapyDevice: Penile pump

Placebo

PLACEBO COMPARATOR

Placebo shockwaves

Device: Placebo LI-ESWTDevice: Penile pump

Interventions

low-intensity extracorporeal shockwave therapyDEVICE

Active shockwaves

Intervention
Placebo LI-ESWTDEVICE

Placebo shockwaves

Placebo
Penile pumpDEVICE

both groups will be treated with a penile pump

InterventionPlacebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense university hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 21, 2018

Study Start

March 13, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

DK(1)