Minimal Invasive Urology Society Benign Prostatic Obstruction (BPO) Study Group Data Collection Project
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry
研究概览
简要总结
This national, multicenter, prospective registry aims to collect standardized perioperative and follow-up data on patients undergoing minimally invasive surgical management for benign prostatic obstruction (BPO) in Turkey. Procedures include transurethral resection of the prostate (TURP), holmium/thulium laser enucleation (HoLEP/ThuLEP), Rezum®, and other contemporary techniques. By prospectively recording patient characteristics, surgical details, and postoperative outcomes in a unified electronic database, the project seeks to provide high-quality real-world evidence to support clinical decision-making, guideline updates, and future hypothesis-driven sub-studies.
详细描述
The ReMIUS-BPO registry is designed as a prospective, observational, multicenter cohort study under the coordination of the Minimal Invasive Urology Society. Participating centers will record preoperative, intraoperative, and postoperative data of patients undergoing minimally invasive surgery for BPO using a secure, standardized electronic case report form. Preoperative variables include demographics, comorbidities, medication history, prostate volume, and validated symptom scores (IPSS, OAB-V8). Intraoperative data include surgical technique, energy source, operative time, and complications. Postoperative follow-up will record early and late complications, catheterization time, changes in symptom scores, and re-intervention rates.
The registry aims to:
- Create a comprehensive, analyzable national dataset for BPO surgery.
- Compare surgical outcomes between different energy sources.
- Evaluate the impact of the learning curve on operative time.
- Determine long-term reoperation rates. The data will serve as a platform for future hypothesis-driven studies and potential embedded randomized controlled trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients ≥ 18 years old
- •Diagnosis of BPO with clinical indication for minimally invasive surgery
- •Signed informed consent
- •Availability of complete baseline and follow-up data
排除标准
- •No informed consent
- •Missing essential preoperative or follow-up data
结局指标
主要结局
Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry
时间窗: Within 12 months after each patient's surgery date
Percentage of eligible patients undergoing minimally invasive surgical treatment for BPO whose data sets are complete for all predefined variables (baseline characteristics, perioperative details, and follow-up outcomes) in the national MIUS registry. Completeness is defined as ≥95% of required data fields filled for each case.
次要结局
- Comparison of perioperative complication rates between surgical techniques(up to 4 weeks)
- Change in International Prostate Symptom Score (IPSS)(Baseline to 12 months post-surgery)
- Change in maximum urinary flow rate (Qmax)(Baseline to 12 months post-surgery)
- Reoperation-free survival(Up to 5 years post-surgery)
研究者
Murat Gulsen
Assistant Professor
Ondokuz Mayıs University