Predictors of Trifecta Achievement After Holmium Laser Enucleation of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Trifecta achievement three months after HoLEP
研究概览
简要总结
Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment option for men experiencing bothersome lower urinary tract symptoms due to an enlarged prostate. Researchers predict that specific participant or operator-dependent conditions before or during HoLEP may influence the trifecta outcome, based on similar studies. Therefore, the aim of this study is to understand what these conditions are. Trifecta success indicates a high-quality surgery based on three essential criteria: the treatment's effectiveness, ease of recovery, and the absence of serious side effects. In this study, trifecta is defined as relief from bothersome symptoms validated by international symptom score questionnaires, no urinary incontinence, and no serious events occurring within three months after HoLEP.
详细描述
This study aims to identify preoperative and perioperative variables influencing trifecta achievement in HoLEP surgery and to determine the predictive value of these variables.
Based on the analysis of the collected data, it is anticipated that one or more variables will show a statistically significant association with trifecta outcomes.
Additionally, the study seeks to evaluate the predictive value of these variables for successfully reaching the trifecta. Based on our analysis of the collected data, we expect that one or more of these variables will show a statistically significant association with trifecta outcomes.
Lower urinary tract symptoms (LUTS) are defined by the International Continence Society (ICS) as a constellation of complaints originating from lower urinary tract organs, such as the bladder, prostate, urethra, adjacent pelvic floor muscles, and distal ureters. A large-scale epidemiological study has shown that the prevalence of LUTS in men over 40 years of age is 62%, increasing with advancing age. LUTS in older men are most commonly attributed to benign prostatic obstruction (BPO), and autopsy series have reported benign prostatic hyperplasia (BPH) histology in 60-80% of cases. All patients who are refractory to medical treatment or present with complications are candidates for surgical therapy.
In selecting the surgical approach, patient comorbidities, bladder neuromuscular function, and prostate volume are key determinants. Transurethral laser enucleation techniques (HoLEP, ThuLEP) are non-inferior to conventional methods in BPO surgery and even demonstrate advantages in patients in whom antiplatelet or anticoagulant therapy cannot be discontinued; accordingly, they have been incorporated into the European Association of Urology guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male patients aged ≥ 40 years who are candidates for surgical treatment for BPO.
- •Ability to provide informed consent, when required.
排除标准
- •Clinically proven active condition(s) that require another intervention other than BPO surgery, such as lower urinary tract malignancy, urethral stricture, or neurogenic lower urinary tract symptoms.
- •History of previous surgery for BPO, urethral stricture, or prostate cancer.
- •Incomplete baseline or procedural data.
研究组 & 干预措施
HoLEP
Only arm is the participants who are eligible to undergo HoLEP. Single arm, determination of predictors of the trifecta.
干预措施: Transurethral Holmium Laser Enuclation of the Prostate (Procedure)
结局指标
主要结局
Trifecta achievement three months after HoLEP
时间窗: From enrollment to the three months after the intervention for each participant.
Achievement of all three of the following criteria, three months after HoLEP: 1. At least a 30% reduction in International Prostate Symptom Score (IPSS) 2. Absence of major complications (no Clavien-Dindo grade \> II), 3. No urinary incontinence
次要结局
- Length of Hospital Stay After the Intervention(Perioperative/Periprocedural)
- Change in peak urinary flow rate (Qmax)(Starting one month after the intervention and continuing for one year after the intervention, with multiple measurements.)
研究者
Murat Gulsen
Assistant Professor
Ondokuz Mayıs University