Actively Recruiting
Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease: Case Series
Led by Centro de Atenção ao Assoalho Pélvico · Updated on 2024-05-29
10
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical response of a combined treatment using non-ablative radiofrequency and low-intensity shock wave therapy in men with Peyronie's disease. This one-arm clinical trial aims to determine if this treatment is safe and whether it improves symptoms such as sexual function, pain, and penile erection. The study also explores the impact of this therapy on quality of life and psycho-emotional aspects like anxiety and depression. The treatment involves applying monopolar non-ablative radiofrequency and electromagnetic low-intensity shock wave therapy directly to the fibrotic plaque on the penis. Treatments are given 2 to 5 times a week, depending on the patient's availability, for a total of 24 sessions. Specific devices are used to deliver radiofrequency at a controlled temperature and shock waves with set energy and frequency parameters to the affected area. Participants will complete five validated questionnaires and undergo physical assessments including palpation and ultrasound of the fibrotic plaque. Evaluations occur before treatment, after treatment, and one month post-treatment. Satisfaction and symptom changes are measured regularly during treatment. Telephone follow-ups at 3, 6, 9, and 12 months after treatment assess long-term effects. Researchers will monitor sexual function, pain, erection quality, and psychosocial factors throughout the study.
CONDITIONS
Brief Title
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical complaint related to Peyronie's disease
- At any stage of the disease (acute or chronic)
You will not qualify if you...
- Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant
- Metallic implants over or under the area to be treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 24 sessions over 2 to 5 times a week according to participant availability
Participants receive non-ablative radiofrequency and low-intensity shock wave therapy applied to the fibrotic plaque in the penis.
Multiple visits, 2 to 5 times a week for 24 sessions
Duration - Up to 12 months
Participants are monitored for clinical response in sexual function, pain, penile erection, and psycho-emotional aspects up to 12 months after treatment.
Visits at 8 weeks, then at 1, 3, 6, 9, and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, Brazil, 40.290-000
Actively Recruiting
Research Team
C
Carlos Mamede, doctorade
P
Patrícia Lordelo, post-PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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