Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
研究概览
简要总结
Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)
详细描述
While prostate laser enucleation is being confirmed as the new gold standard for surgical management of benign prostate hypertrophy, the holmium:Yag laser is currently the most widely used. A new laser technology, the fibrous thulium laser (TFL), has recently appeared with clearly superior results for lithotripsy. The question therefore arises of the surgical and functional results of the use of fibrous thulium for prostate enucleation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients superior or equal to 18 years old
- •Benign Prostate Hypertrophy ( more than 30cc.)
- •Indication to surgical treatment
- •No contraindication for surgery
- •No opposition to participating in the study
排除标准
- •Evidence of urethral stenosis
- •Evidence of a bladder tumour
- •Evidence of prostate cancer known or confirmed by prostate biopsies if suspected
- •Known neurological bladder
- •Refusal to participate
结局指标
主要结局
Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
时间窗: MONTH 12
self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
次要结局
- duration of intervention(POST SURGERY HOUR 24)
- max flow assessment(MONTH 1)
- quality of life assessment(MONTH 1)
- bloodloss assessment(Day 1)
- Rate of post-operative complications(MONTH 6)
- erectile dysfunction assessment(MONTH 1)
- prostatic specific antigen in ng/mL level evolution(MONTH 1)
- Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL(MONTH 6)
- PATIENT GLOBAL IMPRESSION OF SEVERITY(MONTH 1)
- post-void residual (PVR) urine test(MONTH 1)
- PATIENT GLOBAL IMPRESSION OF IMPROVEMENT(MONTH 1)
- urinary incontinence Assessment(MONTH 1)
研究者
MALVAL Benoit
Principal Investigator, Doctor in urology department
Clinique Saint-Hilaire