Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.

Macquarie University0 个研究点目标入组 24 人开始时间: 2021年7月15日最近更新: 2021年7月21日

适应症

试验速览

暂无简介。

•The Novoglan-01 study inclusion criteria are as follows.
•1.Male 18 or older referred to the urology clinic
•2.Symptoms of adult phimosis with inability to fully retract the foreskin
•3.Reporting of pain or discomfort
•4.Potential participant may have Balanitis Xerotica Obliterans or undergone prior frenuloplasty
•5.Willingness to provide informed consent and willingness to participate and comply with the study requirements.

•The Novoglan-01 study exclusion criteria are as follows.
•1.Any known allergy to latex or silicones
•2.Any bleeding, ulcer or active infection of the penis
•3.Any prior prepuce surgery, except for frenuloplasty
•4.Any hypospadia
•5.Any severe scaring of the glans or foreskin
•6.Any history of penile cancer
•7.Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements

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