Intralesional Injection of Hyaluronic Acid Compared With Verapamil in Peyronie's Disease: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Penile curvature degree
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intralesional treatment with Hyaluronic acid
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.
干预措施: Intralesional treatment with Hyaluronic acid (Drug)
Intralesional treatment with Verapamil
Patients will receive intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks.
干预措施: Intralesional treatment with Verapamil (Drug)
结局指标
主要结局
Penile curvature degree
时间窗: 12 weeks postoperatively
The change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree).
次要结局
- Plaque size (mm)(12 weeks postoperatively)
研究者
Ahmed Abou Elezz Abdel Fattah
Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt
Benha University
