Peyronie Disease Clinical Trial
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.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03774264 -
Treatment Response to Xiaflex for Men With Peyronie's Disease
|
||
| Recruiting |
NCT05777031 -
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
|
Phase 4 | |
| Active, not recruiting |
NCT05871177 -
Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)
|
N/A | |
| Recruiting |
NCT05768867 -
French Translation and Validation of the PEYronie's Disease QUESTionnaire
|
||
| Recruiting |
NCT04512287 -
PRP for Treatment of Peyronie's Disease
|
Phase 2 | |
| Withdrawn |
NCT05646602 -
Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
|
N/A | |
| Completed |
NCT04052217 -
Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
|
N/A | |
| Recruiting |
NCT06303661 -
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease
|
N/A | |
| Recruiting |
NCT06065436 -
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
|
N/A | |
| Recruiting |
NCT05316714 -
Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment
|
N/A | |
| Completed |
NCT04370652 -
Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum
|
||
| Active, not recruiting |
NCT05480683 -
Pelvic CT With Agatston Calcium Score for Peyronie Disease
|
N/A | |
| Recruiting |
NCT04821115 -
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
|
N/A |