Clinical trial NCT03530540: Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peyronie Disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in penile curvature
timeFrame: penile curve will be assessed at baseline, and 1,3 and 6 months.
Secondary outcomes:
measure: Change in pain score using the Visual Analogue Scale (VAS)
timeFrame: VAS will be assessed at baseline, and 1,3 and 6 months.
measure: Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).
timeFrame: IIEF-5 will be assessed at baseline, and 1,3 and 6 months.
measure: Change in Peyronies disease questionnaire score
timeFrame: Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense university hospital
Study officials:
References: