Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postvoid Residual Urine (PVRU) Volume
研究概览
简要总结
Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution
详细描述
The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent voluntarily and will be willing to follow-up
- •Prostate volume <80 g
- •Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention)
- •The use of antiplatelet agents or anticoagulant drugs is allowed.
排除标准
- •Previous history of pelvic surgery
- •Previous history of pelvic radiotherapy
- •Previous history of neurogenic bladder dysfunction
- •Documented or suspected prostate carcinoma
- •Patients with severe cardiopulmonary disease or severe mental disorders
- •Poor compliance, and can not be followed up.
研究组 & 干预措施
M-TURP
The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
干预措施: Transurethral Resection of the Prostate (TURP) (Device)
PK-TURP
The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
干预措施: Transurethral Resection of the Prostate (TURP) (Device)
结局指标
主要结局
Postvoid Residual Urine (PVRU) Volume
时间窗: 12 months
Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
International Prostate Symptom Score (IPSS)
时间窗: 12 months
International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories * Mild LUTS: 0-7 points * Moderate LUTS: 8-19 points * Severe LUTS: 20-35 points
Maximum Urinary Flow Rate (Qmax
时间窗: 12 months
Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
次要结局
- Clavien Dindo System(12 months)
- Number of Participants Reporting Sexual Activity in the Last Month(12 months)
- Operative Time(Up to 24 hours)
- Hospital Stay(1 month)
- Catheter Duration(1 month)
- Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire(12 months)
- International Index of Erectile Function (IIEF-5)(12 months)
- Prostate Volume (PV)(12 months)
- Irrigation Volume(Up to 24 hours)
- Change in Plasmatic Sodium in 24 Hours Post-operation(24 hours after surgery)
- Change in Haemoglobin in 24 Hours Post-operation(24 hours after surgery)
- Transfusion Rate(1 month)
- Resected Tissue Weigh(Up to 24 hours)
- Speed Resection(Up to 24 hours)
- Sequelae Rate: Retrograde Ejaculation(12 months)
- Resected Tissue Percentage(Up to 24 hours)
- Late Reoperation Rate(12 months)
- Early Reoperation Rate(1 month)
- Post-TURP Syndrome Rate(Up to 24 hours)
- Bleeding Complications Rate(1 month)
- Urinary Tract Infections Rate(12 months)
- Stenotic Complications Rate: Meatal Stenosis(12 months)
- Stenotic Complications Rate: Urethral Stricture(12 months)
- Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate(12 months)
- Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate(12 months)
- Sequelae Rate: Dysuria(12 months)
- Stenotic Complications Rate: Bladder Neck Contracture(12 months)
- Stress Urinary Incontinence Rate(12 months)
研究者
Carolina Alonso
Attending physician
Hospital Universitario de Fuenlabrada