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Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease

Primary Purpose

Peyronie's Disease, Hyaluronic Acid, Verapamil

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intralesional treatment with Hyaluronic acid
Intralesional treatment with Verapamil
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peyronie's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intralesional treatment with Hyaluronic acid

    Intralesional treatment with Verapamil

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Plaque size (mm)
    The change in plaque size (mm) will be recorded

    Full Information

    First Posted
    May 3, 2023
    Last Updated
    May 3, 2023
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05855070
    Brief Title
    Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease
    Official Title
    Intralesional Injection of Hyaluronic Acid Compared With Verapamil in Peyronie's Disease: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 20, 2023 (Anticipated)
    Primary Completion Date
    May 20, 2024 (Anticipated)
    Study Completion Date
    May 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peyronie's Disease, Hyaluronic Acid, Verapamil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intralesional treatment with Hyaluronic acid
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Intralesional treatment with Verapamil
    Arm Type
    Experimental
    Arm Description
    Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Intralesional treatment with Hyaluronic acid
    Intervention Description
    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
    Intervention Name(s)
    Intralesional treatment with Verapamil
    Intervention Description
    Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Penile curvature degree
    Description
    The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).
    Time Frame
    12 weeks postoperatively
    Secondary Outcome Measure Information:
    Title
    Plaque size (mm)
    Description
    The change in plaque size (mm) will be recorded
    Time Frame
    12 weeks postoperatively

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Sexually active men older than 18 years affected by Peyronie's Disease
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abou Elezz, MD
    Phone
    01228555403
    Ext
    +2
    Email
    ahmed.aboelezz@fmed.bu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease

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