Peyronie DiseaseNCT06303661
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease
A study testing Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in people with Peyronie Disease, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial summary
The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2024to Jun 2026
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical complaint related to Peyronie's disease;
- At any stage of the disease (acute or chronic).
Who cannot join
- Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant;
- Metallic implants over or under the area to be treated.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
Patricia V Lordelo, Phd, +5571988592400, pvslordelo@hotmail.com
Carlos Mamede, Phd
About this study
Official title: Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease: Case Series
The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.
- Conditions
- Peyronie Disease
- Being tested
- Non-ablative Radiofrequency, Low-intensity Shock Wave Therapy
- Keywords
- Peyronie Disease, Non ablative radiofrequency, Low-intensity Shock Waves Therapy
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative RadiofrequencyDevice
There are two electrodes: one active, which will be used on the penis, using a non-lubricated condom from the Blowtex brand, using pharmaceutical glycerin to emit radiofrequency inside and outside the condom, and another electrode, dispersive, wrapped in PVC-type plastic film, coupled to the region of the patient's penis where there is no fibrotic plaque, which will act as earth and the temperature to be used in the treatment will be 38°C. When the desired heating is reached, the device maintains the temperature and thus the radiofrequency application will be maintained for 2 minutes.
Low-intensity Shock Wave TherapyDevice
The equipment's applicator is covered with transparent PVC film and non-alcoholic gel is used as a coupling medium between the applicator and the penis. The following parameters are used: frequency of 10Hz, energy of 120mJ and 2,000 shots in the fibrotic plaque.
| Study group | Role | What they receive |
|---|---|---|
| RF and SWT | Experimental | The treatment will be carried out through the application of monopolar non-ablative radiofrequency (IBRAMED, Amparo, São Paulo, Brazil - model Neartek) associated with electromagnetic low-intensity shock wave therapy (IBRAMED, Amparo, São Paulo, Brazil - model THOOR) on the fibrotic plaque in the penis, 2 to 5 times a week, according to the patient's availability, totaling 24 sessions. Receives: Device: Non-ablative Radiofrequency; Device: Low-intensity Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function.
It will be measured by the questionnaire International Index of Erectile Dysfunction (IIEF-5). Lower values represent worse sexual function and are categorized as follows: 5-7 points represents severe erectile dysfunction, 8-11 points represents moderate erectile dysfunction, 12-16 represents mild to moderate erectile dysfunction, 17 -21 represents mild erectile dysfunction and 22-25 means no erectile dysfunction.
Measured: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain.
The level of pain will be assess by the question three questions of Peyronie's Disease Questionnaire (PDQ). Each of the three questions score from 0 to 10, so the total range will be from 0 to 30. The lower the score, the less pain the patient feels.
Measured: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection.
The quality of penile erection will be measured by the Quality of Erection Questionnaire. The final score can vary between 0 and 100 points, with the higher the score, the better the quality of the erection.
Measured: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
Secondary outcomes (2)
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression.
It will be measured by the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36). The final score for each domain ranges from 0 to 100 (there are two - body and mental), there is no cutoff point and higher scores indicate a better health status.
Measured: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression.
It will be measured by the questionnaire Scale Hospital for Anxiety and Depression. It is composed of two subscales, one for anxiety and the other for depression, with seven items each. The global score on each subscale ranges from 0 to 21. The lower the score, the lower level of anxiety/or depression.
Measured: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start8 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Combination of two therapies with conservative devices is proposed.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303661
- Sponsor's protocol ID
- 74001323.3.0000.5544
- Status last verified
- May 2024
- First submitted
- 4 Dec 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease: Case Series
- ClinicalTrials.gov ID
- NCT06303661
- Acronym / sponsor ID
- 74001323.3.0000.5544
- Conditions
- Peyronie Disease
- Keywords
- Peyronie Disease, Non ablative radiofrequency, Low-intensity Shock Waves Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Mar 2024 (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 goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Combination of two therapies with conservative devices is proposed.
| Arm | Type | Receives |
|---|---|---|
| RF and SWT | Experimental | Device: Non-ablative Radiofrequency, Device: Low-intensity Shock Wave TherapyThe treatment will be carried out through the application of monopolar non-ablative radiofrequency (IBRAMED, Amparo, São Paulo, Brazil - model Neartek) associated with electromagnetic low-intensity shock wave therapy (IBRAMED, Amparo, São Paulo, Brazil - model THOOR) on the fibrotic plaque in the penis, 2 to 5 times a week, according to the patient's availability, totaling 24 sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical complaint related to Peyronie's disease;
- At any stage of the disease (acute or chronic).
Key exclusion criteria (2 listed)
- Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant;
- Metallic implants over or under the area to be treated.
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 |
|---|---|---|
| Non-ablative RadiofrequencyThere are two electrodes: one active, which will be used on the penis, using a non-lubricated condom from the Blowtex brand, using pharmaceutical glycerin to emit radiofrequency inside and outside the condom, and another electrode, dispersive, wrapped in PVC-type plastic film, coupled to the region of the patient's penis where there is no fibrotic plaque, which will act as earth and the temperature to be used in the treatment will be 38°C. When the desired heating is reached, the device maintains the temperature and thus the radiofrequency application will be maintained for 2 minutes. | Device | RF and SWT |
| Low-intensity Shock Wave TherapyThe equipment's applicator is covered with transparent PVC film and non-alcoholic gel is used as a coupling medium between the applicator and the penis. The following parameters are used: frequency of 10Hz, energy of 120mJ and 2,000 shots in the fibrotic plaque. | Device | RF and SWT |
Primary outcome
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function.
Time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It will be measured by the questionnaire International Index of Erectile Dysfunction (IIEF-5). Lower values represent worse sexual function and are categorized as follows: 5-7 points represents severe erectile dysfunction, 8-11 points represents moderate erectile dysfunction, 12-16 represents mild to moderate erectile dysfunction, 17 -21 represents mild erectile dysfunction and 22-25 means no erectile dysfunction.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain.
Time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
The level of pain will be assess by the question three questions of Peyronie's Disease Questionnaire (PDQ). Each of the three questions score from 0 to 10, so the total range will be from 0 to 30. The lower the score, the less pain the patient feels.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection.
Time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
The quality of penile erection will be measured by the Quality of Erection Questionnaire. The final score can vary between 0 and 100 points, with the higher the score, the better the quality of the erection.
2 secondary outcomes
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression.
Time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression.
Time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in people with Peyronie Disease, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
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 2 inclusion and 2 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Carlos Mamede, doctorade (55 71 996673967, carlosmamede@bahiana.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function. (time frame: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.). The study lists 3 primary outcomes in all. 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 29 May 2024.