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

O

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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