An Open Prospective Clinical Study on Safety and Efficacy of Surgical Treatment of Patients With Anterior Urethral Stricture Using a Tissue-engineered Construct Based on Autologous Buccal Mucosa Cells and Matrix From Reconstituted Collagen and Reinforcing Polylactoglycolide Fibers
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
This study investigates safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct based on autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This is a single arm study with no control. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at five years.
详细描述
Treatment of urethral strictures longer than 2 cm is an actual clinical challenge. In this case, the common method is replacement surgery using a buccal mucosa graft. However, the main disadvantage of this method is associated with limited donor resources and donor site morbidity.
The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct. The construct consists of autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. Patients will be followed up for 5 years within this study. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, biopsy, and quality of life monitoring. Telephone follow-up will take place in between these assessments.
The data obtained from this study will have practical implications for the urethral stricture treatment and will be based on the principles of evidence-based medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient signed informed consent form
- •Diagnosed anterior urethral stricture longer than 2.0 cm and shorter than 4.0 cm
- •At least one prior internal optical urethrotomy and/or urethral bougienage
- •Non-inclusion Criteria:
- •Acute infectious diseases
- •Patient with decompensated heart and renal failure
- •Patient with non-compensated diabetes mellitus
- •Patient with malignant tumor
- •Patient with polyvalent allergy
- •Mental disorders
- •Post traumatic urethral strictures
- •Subtotal and total urethral strictures
- •Sexually transmitted infections
- •Hypersensitivity to any components of tissue-engineered constructs
- •Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
- •Other associated urethral strictures
- •Laboratory markers of active urethritis
排除标准
- •Patient's refusal from the further participation in trial
- •Confirmed syphilis, HIV, hepatitis B or C infections
- •Patient who cannot be regularly examined due to any circumstances
结局指标
主要结局
Serious adverse events
时间窗: 4 weeks after surgery
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
时间窗: 4 weeks after surgery
Frequency, type and severity of serious adverse reactions (SAR)
次要结局
- Pericatheter urethrography(4 weeks after surgery)
- Urodynamic changes via uroflowmetry - 4(5 years)
- Biopsy(4 months after surgery)
- Quality of life monitoring - 1(5 years)
- Voiding cystourethrography(5 years)
- Urodynamic changes via uroflowmetry - 2(5 years)
- Urodynamic changes via uroflowmetry - 1(5 years)
- Urodynamic changes via uroflowmetry - 3(5 years)
- Quality of life monitoring - 2(5 years)
- Retrograde urethrography(5 years)
研究者
Denis Butnaru, MD
Director
I.M. Sechenov First Moscow State Medical University