PDF(Pubmed)
Abstract：
UNASSIGNED: At present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment.
UNASSIGNED: A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4-8 weeks with patient\'s degree of phimosis assessed before and at 6-8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment.
UNASSIGNED: The treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects.
UNASSIGNED: The Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment.
UNASSIGNED: The Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.
UNASSIGNED: A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4-8 weeks with patient\'s degree of phimosis assessed before and at 6-8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment.
UNASSIGNED: The treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects.
UNASSIGNED: The Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment.
UNASSIGNED: The Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.
摘要：
■目前，成人包茎的唯一明确治疗方法是包皮环切术,这是一个手术切除包皮。Novoglan是一种新颖的设备，可以为包茎患者提供手术的替代方法。它基于定制成型的气球的应用，用于逐渐的皮肤重塑和包皮扩张。这项开放标签的临床试验旨在研究安全性，Novoglan治疗的疗效和耐受性。
■对在麦考瑞大学医院和亚历山德拉公主医院招募的20名成人包茎患者进行了一项前瞻性试验。经过资格筛选和登记，患者接受了Novoglan产品和培训.治疗包括每天两次10分钟的应用，持续时间为4-8周，在开始治疗之前和之后6-8周评估患者的包茎程度。参与者还被要求完成旨在评估Novoglan治疗的安全性和耐受性的问卷。
■治疗成功，90％的患者包皮回缩得到改善，所有患者在治疗后都实现了包皮完全回缩。95%的患者报告焦虑水平降低，超过60%的患者报告性活动期间或一般疼痛/不适减轻。同样，95％的患者对治疗中度至非常满意，并会向其他人推荐Novoglan。没有观察到不良事件，只有15％的参与者报告了轻微的副作用。
■Novoglan-01试验证明了很高的安全性，Novoglan治疗成人包茎的疗效和耐受性及其作为包皮环切术或类固醇乳膏治疗的保守替代方案的高潜力。
■Novoglan-01研究已在澳大利亚和新西兰临床试验注册中心注册，参考号为ACTRN12621000924853，日期为2021年7月15日。
■对在麦考瑞大学医院和亚历山德拉公主医院招募的20名成人包茎患者进行了一项前瞻性试验。经过资格筛选和登记，患者接受了Novoglan产品和培训.治疗包括每天两次10分钟的应用，持续时间为4-8周，在开始治疗之前和之后6-8周评估患者的包茎程度。参与者还被要求完成旨在评估Novoglan治疗的安全性和耐受性的问卷。
■治疗成功，90％的患者包皮回缩得到改善，所有患者在治疗后都实现了包皮完全回缩。95%的患者报告焦虑水平降低，超过60%的患者报告性活动期间或一般疼痛/不适减轻。同样，95％的患者对治疗中度至非常满意，并会向其他人推荐Novoglan。没有观察到不良事件，只有15％的参与者报告了轻微的副作用。
■Novoglan-01试验证明了很高的安全性，Novoglan治疗成人包茎的疗效和耐受性及其作为包皮环切术或类固醇乳膏治疗的保守替代方案的高潜力。
■Novoglan-01研究已在澳大利亚和新西兰临床试验注册中心注册，参考号为ACTRN12621000924853，日期为2021年7月15日。
