Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease

NCT05855070 | Unknown

• 1 other identifier: RC 6-5-2023
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peyronie's Disease; Hyaluronic Acid; Verapamil

Outcome Measures

Primary Outcomes (1)

• Penile curvature degree

  The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).

  12 weeks postoperatively

Secondary Outcomes (1)

• Plaque size (mm)

  12 weeks postoperatively

Study Arms (2)

Intralesional treatment with Hyaluronic acid

EXPERIMENTAL

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

Intralesional treatment with Verapamil

EXPERIMENTAL

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

Interventions

Intralesional treatment with Hyaluronic acid 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 Hyaluronic acid

Intralesional treatment with Verapamil DRUG

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

Intralesional treatment with Verapamil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Sexually active men older than 18 years affected by Peyronie's Disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Penile Induration

Interventions

Hyaluronic Acid; Verapamil

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

Ahmed Abou Elezz, MD

CONTACT

01228555403; ahmed.aboelezz@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: May 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study.