Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events at 12 months
研究概览
简要总结
In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to direct visual urethrotomy (DVIU) in the treatment of urethral strictures.
详细描述
In this study the investigators wish to proof the concept of free fat grafting into urethral stricture via urethroscope. The investigators will recruit twenty male patients suffering from (endoscopy proven) benign stricture of spongy urethra. All recruited patients have undergone at least one direct visual internal urethrotomy (DVIU) before recruitment. IPSS-score and uroflowmetry are recorded upon recruitment. The IPSS-score is repeated one day preoperatively. Urine sample is gathered for bacterial and cytological analysis. Prophylactic single dose levofloxacin antibiotic is orally administered before operation.
The operation is performed in the operation room by one urologist and one surgeon under general anesthesia. First abdominal liposuction (roughly 20 ml) and fat graft preparation is performed. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Then urethroscopy is performed, urethral stricture is visually graded (location, length, lumen), photographed, DVIU performed and nano fat graft (0,1-0,5ml) injected to stricture site beneath the mucosal layer at three locations. Urinary Foley ch 18 catheter is inserted. Patients are discharged the next day. Urinary catheter is removed after 20 hours.
Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and the patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to the hospital.
Three months later uroflowmetry, urethroscopy and IPSS-questionnaire are repeated. Stricture site is photographed and visually graded. In case of symptomatic re-stricture, the DVIU and fat grafting is repeated once. After 12 months uroflowmetry and IPSS-questionnaire are repeated. In case of suspected re-stricture the urethroscopy is repeated. Follow-up time is 12 months from the last fat graft injection.
Trial starts in fall 2019. The clinical studies have been completed and the data analysis and writing of the manuscript will be finalized in 2022.
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Urethral stricture that has re-occurred at least once.
排除标准
- •Malignant etiology of urethral stricture
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events at 12 months
时间窗: 12 months
Types, severity and probability of procedure related adverse events
Incidence of Treatment-Emergent Adverse Events at 3 months
时间窗: 3 months
Types, severity and probability of procedure related adverse events
次要结局
- Change from Baseline Uroflowmetry at 3 months(3 months)
- Change from Baseline Uroflowmetry at 12 months(12 months)
- Change from Baseline IPSS at 3 months(3 months)
- Change from Baseline IPSS at 12 months(12 months)
- Change from Baseline Stricture Lumen diameter at 3 months(3 months)
- Change from Baseline Stricture Lumen diameter at 12 months(12 months)
研究者
Hannes Kortekangas
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery
Turku University Hospital