Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease

NCT ID: NCT05855070

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2024-05-20

Brief 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.

Detailed 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 .

Conditions

Peyronie's Disease; Hyaluronic Acid; Verapamil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intralesional treatment with Hyaluronic acid

Patients will receive intralesional treatment with Hyaluronic acid (0.8% highly purified sodium salt Hyaluronic acid 6 mg/2 mL; Sinovial, IBSA, Lodi, Italy) weekly for 12 weeks.

Group Type: EXPERIMENTAL

Intralesional treatment with Hyaluronic acid

Intervention Type: DRUG

Patients will receive intralesional treatment with Hyaluronic acid (0.8% highly purified sodium salt Hyaluronic acid16 mg/2 mL; Sinovial, IBSA, Lodi, Italy) weekly for 12 weeks.

Intralesional treatment with Verapamil

Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.

Group Type: EXPERIMENTAL

Intralesional treatment with Verapamil

Intervention Type: DRUG

Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.

Interventions

Intralesional treatment with Hyaluronic acid

Patients will receive intralesional treatment with Hyaluronic acid (0.8% highly purified sodium salt Hyaluronic acid16 mg/2 mL; Sinovial, IBSA, Lodi, Italy) weekly for 12 weeks.

Intervention Type: DRUG

Intralesional treatment with Verapamil

Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient's age from >18 - 70 years old.
• A palpable nodule or plaque in the tunica of the penis
• Presence of pain in the flaccid state or during painful erections.
• Progressive penile curvature >15° and/or penile pain in the flaccid state or at the erection in the last 12 months

Exclusion Criteria

• Patient refusal.
• Calcified plaques or hourglass deformity as defined at duplex Doppler ultrasonography,
• Previous Peyronie's Disease therapy with oral agents or intralesional injections
• Severe concomitant erectile dysfunction (International Index of Erectile Function [IIEF-5] score < 7).
• Congenital penile curvature, history of previous penile surgery, a concomitant oral treatment for Peyronie's Disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abou Elezz Abdel Fattah

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Abou Elezz, MD

Role: CONTACT

ahmed.aboelezz@fmed.bu.edu.eg

01228555403 ext. +2

Other Identifiers

RC 6-5-2023

Identifier Type: -

Identifier Source: org_study_id