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.
Sponsor study identifier
interventional
50
1 country
1
Study Start
March 13, 2018
Actual (reported)Primary Completion
February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2018
Actual (reported)May 7, 2018
Actual (reported)May 21, 2018
Actual (reported)February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
Active shockwaves
Placebo shockwaves
Active shockwaves
Placebo shockwaves
Odense university hospital
Odense, 5000, Denmark
First Submitted
May 7, 2018
First Posted
May 21, 2018
Study Start
March 13, 2018
Actual (reported)Primary Completion
February 1, 2020
Estimated (date passed)both groups will be treated with a penile pump
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 14, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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