Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05855070 |
| Other study ID # |
RC 6-5-2023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2023 |
| Est. completion date |
May 20, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Benha University |
| Contact |
Ahmed Abou Elezz, MD |
| Phone |
01228555403 |
| Email |
ahmed.aboelezz[@]fmed.bu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the present study is to investigate whether intralesional injections of Hyaluronic
acid in the acute phase could reduce the progression of Peyronie's disease thanks to its
interference with inflammatory and pro-fibrotic processes.
Therefore, a prospective, longitudinal, double-blinded, randomized clinical study, has been
designed to evaluate and compare the efficacy and safety of intralesional HA as compared with
the use of verapamil injection in patients affected by Peyronie's disease.
Description:
Peyronie's disease is defined as a chronic benign condition characterized by the formation of
localized fibrous inelastic scars at the level of the tunica albuginea of the penis. This
condition can lead to penile curvature, painful erections and erectile dysfunction.
Peyronie's disease is believed to affect 3% to 9% of the male population, with a higher
prevalence among patients suffering from erectile dysfunction, diabetes and cardiovascular
disease .
The etiology of Peyronie's disease is largely unknown. According to current popular theories,
a single traumatic event or repeated microtraumas during sexual activity can lead to a
low-level autoimmune response arising from a prolonged and complex inflammatory reaction of
the tunica albuginea fibers,5 which leads to plaque formation.
The Peyronie's disease presents 2 different phases: active or acute and stable or chronic. It
is paramount to distinguish between acute and chronic phase of the condition, since
management is different in the 2 phases. Plaque formation and calcification generally take
place during the acute phase, which can last for up to 18 months. In the chronic phase,
penile pain will be reduced, and penile deformity stabilized. Transition to the chronic phase
is defined when curvature remains stable for at least 3 months.
The European Association of Urology and the American Association of Urology have released
clinical practice guidelines for the diagnosis, evaluation, treatment, and follow-up of
patients with Peyronie's disease.
Treatment of Peyronie's disease includes both medical and surgical approaches and the
management is tailored to the phase of the disease, the degree of deformity, the quality of
the erections and patient's choice.
Conservative treatment of Peyronie's disease is focused primarily on patients in the early
(acute inflammatory) stage, and surgical remediation is used to correct curvature, allow for
satisfactory intercourse, and is reserved for patients who have stable disease for at least
12 months .
