Efficacy and safety of a tissue-engineered oral mucosa (MukoCell®) vs. native oral mucosa graft urethroplasty in male patients with urethral stricture

MukoCell GmbH0 个研究点目标入组 200 人开始时间: 2019年3月15日最近更新: 2023年12月12日

适应症

试验速览

暂无简介。

•1.Signed declaration of consent and data protection declaration obtained prior to any trial-specific procedures
•2.Male patient aged =18 and =75 years
•3.Urethral stricture fulfilling the following criteria:
•- Medical need for urethroplasty
•- Located pre-dominantly bulbar
•- No more than 3 previous urethrotomies
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Any urethroplasty in the past
•2.Presence of solely penile stricture
•3.Penile /urethral abnormality (e.g. hypospadia, penile curvature, etc.) interfering with study related assessments
•4.Lichen sclerosis
•5Previous radiation therapy or laser treatment of the urethral region
•6.Acute or chronic urethritis, presence of balanitis
•7.Acute or chronic infections in the oral cavity
•8.Presence of urologic disease(s) interfering with urination
•9.Concomitant therapy with medications that may lead to urinary retention (e.g. anticholinergics etc.)
•10.Severe liver or kidney disease
•11.Severe somatopathic, neurological and /or psychiatric disease(s)
•12.Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before the Screening visit)

发起方

MukoCell GmbH