Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease

Intralesional Injection of Hyaluronic Acid Compared With Verapamil in Peyronie's Disease: A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peyronie's Disease; Hyaluronic Acid; Verapamil
• Intervention / Treatment: Drug: Intralesional treatment with Hyaluronic acid; Drug: Intralesional treatment with Verapamil

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abou Elezz, MD; Phone Number: +2 01228555403; Email: ahmed.aboelezz@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: Intralesional treatment with Verapamil; Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile curvature degree	The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).	12 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque size (mm)	The change in plaque size (mm) will be recorded	12 weeks postoperatively

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2023
• Primary Completion (Anticipated): May 20, 2024
• Study Completion (Anticipated): May 20, 2024

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Viscosupplements; Hyaluronic Acid; Verapamil
• Other Study ID Numbers: RC 6-5-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will be available under a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No