Evaluation of Clinical and Functional Outcomes After Minimally Invasive Prostate Interventions: A Multicenter Prospective REDCap Registry (MIST Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
This study is a multicenter prospective patient registry designed to evaluate clinical, functional, and safety outcomes after minimally invasive prostate interventions (MIST) performed for benign prostatic obstruction (BPO) secondary to benign prostatic hyperplasia (BPH). The interventions included in this registry represent standard-of-care treatment options and may include Rezum water vapor therapy, UroLift prostatic urethral lift, Aquablation, prostatic artery embolization (PAE), iTind, transperineal laser ablation (TPLA), transurethral needle ablation (TUNA), and transurethral microwave therapy (TUMT).
The registry collects standardized data using a secure REDCap platform from participating international centers. Data elements include demographic characteristics, comorbidities, medication use, laboratory parameters, prostate volume assessments, uroflowmetry, post-void residual measurements, patient-reported symptom scores, sexual function assessments, intraoperative details, complications (classified using Clavien-Dindo), and postoperative recovery parameters. Follow-up visits occur at 1, 3, 6, 12, 24, and 36 months, with an optional extended follow-up at 72 months to assess long-term durability and reintervention-free survival.
The primary aim of the study is to evaluate improvements in urinary symptoms (IPSS), quality of life, maximum urinary flow rate (Qmax), and post-void residual volume (PVR) following MIST procedures. Secondary objectives include assessing perioperative safety, catheterization duration, predictors of treatment success or failure, need for reintervention, and long-term preservation of continence and sexual function.
This registry is observational and does not assign or modify any treatment. All procedures are performed based on local clinical practice and physician judgment. Prospective participants provide informed consent. Data collected will be used to generate real-world evidence to guide patient selection, optimize procedural outcomes, and compare clinical performance across different minimally invasive prostate interventions.
详细描述
Benign prostatic obstruction (BPO) secondary to benign prostatic hyperplasia (BPH) is a prevalent cause of lower urinary tract symptoms (LUTS) in aging men. Minimally invasive surgical therapies (MIST) have become increasingly utilized due to their favorable safety profiles, reduced hospitalization times, preservation of sexual function, and quicker return to normal activities. Despite their growing use, comparative real-world data across MIST modalities remain limited, especially regarding long-term functional outcomes and retreatment rates.
The MIST Registry is an investigator-initiated, non-commercial, multicenter, observational cohort study coordinated by the Department of Urology at Necmettin Erbakan University. The aim is to systematically collect high-quality clinical data from centers using a standardized REDCap electronic data capture system. The registry includes patients treated with any guideline-supported minimally invasive prostate intervention, including Rezum, UroLift, Aquablation, prostatic artery embolization (PAE), iTind, TPLA, TUNA, and TUMT. These procedures are performed as part of routine clinical care and not assigned by the study.
Data collection includes demographics, comorbidities, prior BPO treatments, LUTS medication history, PSA levels, prostate volume, presence and size of median lobe, uroflowmetry parameters, PVR, patient-reported outcomes (IPSS, QoL, IIEF-5, MSHQ-EjD), and urodynamic findings when available. Intraoperative data include type of MIST technique, procedure duration, device usage, energy delivery parameters, imaging guidance, estimated blood loss, and intraoperative complications. Postoperative outcomes include catheterization duration, early complications within 30 days, rehospitalization, urinary retention, infections, and device-related events. Complications are categorized according to the Clavien-Dindo classification, and bladder injury can be scored using the BICEP system where relevant.
Follow-up assessments occur at 1, 3, 6, 12, 24, and 36 months, with optional long-term evaluations at 72 months. Outcomes assessed include symptom scores, Qmax, PVR, PSA, medication changes, and any surgical or minimally invasive reinterventions. Statistical analyses will include descriptive summaries, longitudinal comparisons, multivariable modeling to identify predictors of success or failure, and Kaplan-Meier estimates of reintervention-free survival.
The registry is designed to generate real-world evidence that reflects routine clinical practice across diverse populations and healthcare systems. Findings are expected to inform patient selection, refine procedural decision-making, improve counseling on expected outcomes, and support comparative effectiveness research among emerging minimally invasive prostate treatments.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged ≥40 years
- •Diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS) or benign prostatic obstruction (BPO)
- •Undergoing a minimally invasive prostate intervention (Rezum, UroLift, Aquablation, PAE, iTind, TPLA, TUNA, TUMT) as part of standard clinical care
- •Ability and willingness to attend scheduled follow-up visits
- •Prospective participants able to provide written informed consent
- •Retrospective cases eligible if data are fully de-identified and inclusion is approved by local ethics/IRB authorities
排除标准
- •Active urinary tract infection at the time of treatment
- •ASA physical status ≥5
- •Prior pelvic radiotherapy resulting in severe bladder dysfunction
- •Severe cognitive impairment or inability to participate in follow-up
- •Missing essential baseline data (for retrospective entries)
- •Patients receiving experimental or investigational prostate devices or therapies outside routine clinical care
研究组 & 干预措施
MIST_Cohort
Men aged ≥40 years undergoing minimally invasive prostate interventions (Rezum, Urolift, Aquablation, PAE, iTind, TPLA, TUNA, TUMT) as part of routine clinical care. All participants are observed prospectively in a single registry cohort without assignment to treatment.
干预措施: No intervention (Other)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure
IPSS is a validated 0-35 questionnaire assessing lower urinary tract symptoms. Lower scores indicate symptom improvement. Change from baseline will be evaluated at each follow-up visit using patient-reported scores collected via standardized REDCap forms.
Change in maximum urinary flow rate (Qmax)
时间窗: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure
Qmax (mL/s) is measured by uroflowmetry at each clinical visit. Improvement in urinary flow represents treatment effectiveness. Change from baseline will be analyzed longitudinally.
Change in quality of life (QoL) score (IPSS subscore)
时间窗: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure
QoL score ranges from 0-6. Lower scores reflect improved quality of life. Change from baseline is measured using the IPSS-QoL item collected through REDCap.
次要结局
- Change in Post-Void Residual (PVR) volume(Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months)
- Change in sexual function (IIEF-5 score)(Baseline; 1, 3, 6, 12, 24, 36, 72 months)
- Change in ejaculatory function (MSHQ-EjD score)(Baseline; 1, 3, 6, 12, 24, 36, 72 months)
- Catheterization duration(Within first 30 postoperative days)
- Early postoperative complications (Clavien-Dindo classification)(Within 30 postoperative days)
- BICEP bladder injury score(During the procedure)
- Reintervention rate(Up to 72 months)
研究者
Selim Soyturk
Urologist / Coordinating Investigator
Necmettin Erbakan University