Peyronie's DiseaseNCT05855070
Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease
A study testing Intralesional treatment with Hyaluronic acid and Intralesional treatment with Verapamil in people with Peyronie's Disease and Hyaluronic Acid, run by Benha University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Peyronie's Disease, Hyaluronic Acid, Verapamil
- What is being tested?
- Intralesional treatment with Hyaluronic acid and Intralesional treatment with Verapamil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Intralesional treatment with Hyaluronic acid, Intralesional treatment with Verapamil
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional treatment with Hyaluronic acidDrug
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 VerapamilDrug
Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intralesional treatment with Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile curvature degree
The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).
Measured: 12 weeks postoperatively
Secondary outcomes (1)
Plaque size (mm)
The change in plaque size (mm) will be recorded
Measured: 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start20 May 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abou Elezz Abdel Fattah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855070
- Sponsor's protocol ID
- RC 6-5-2023
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Injection of Hyaluronic Acid Compared With Verapamil in Peyronie's Disease: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05855070
- Acronym / sponsor ID
- RC 6-5-2023
- Conditions
- Peyronie's Disease, Hyaluronic Acid, Verapamil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional treatment with Hyaluronic acid | Experimental | Drug: Intralesional treatment with Hyaluronic acidPatients 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. |
| Intralesional treatment with Verapamil | Experimental | Drug: Intralesional treatment with VerapamilPatients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional treatment with Hyaluronic acidPatients 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. | Drug | Intralesional treatment with Hyaluronic acid |
| Intralesional treatment with VerapamilPatients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks. | Drug | Intralesional treatment with Verapamil |
Primary outcome
Penile curvature degree
Time frame: 12 weeks postoperatively
The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).
1 secondary outcome
Plaque size (mm)
Time frame: 12 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes. The study will be available under a reasonable request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional treatment with Hyaluronic acid and Intralesional treatment with Verapamil in people with Peyronie's Disease and Hyaluronic Acid, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abou Elezz, MD (01228555403 ext. +2, ahmed.aboelezz@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile curvature degree (time frame: 12 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.