UNVEIL-BPO Median Lobe Study: An International Multicenter Evaluation of Selective Median Lobe Resection and Enucleation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Proportion of Participants With Composite Clinical Failure at 12 Months
研究概览
简要总结
This prospective multicenter observational cohort study will evaluate clinical outcomes after selective median lobe transurethral surgery for benign prostatic obstruction. Eligible men with lower urinary tract symptoms or urinary retention who are scheduled for selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care will be enrolled and followed after surgery.
The study will collect preoperative clinical data, symptom scores, uroflowmetry, postvoid residual volume, prostate volume, intravesical prostatic protrusion measurements, cystoscopic anatomical findings, intraoperative variables, and postoperative outcomes. The primary outcome is composite clinical failure at 12 months.
The main aim is to identify practical preoperative urology-based anatomical and functional predictors of clinical failure after selective median lobe surgery and to develop an exploratory prediction model that may help improve patient selection in future practice.
详细描述
Selective median lobe transurethral surgery is used in selected men with benign prostatic obstruction in whom the median lobe or high bladder neck median component is considered the dominant obstructive anatomy. This approach may provide urinary improvement while potentially reducing ejaculatory dysfunction compared with complete transurethral prostate surgery. However, some patients may experience persistent or recurrent symptoms because of residual lateral lobe obstruction, unfavorable bladder neck anatomy, insufficient functional improvement, or bladder dysfunction.
This study is designed as a prospective multicenter observational cohort. The surgical decision and the choice of technique will not be assigned by the study protocol. Patients will undergo selective median lobe TURP, selective median lobe HoLEP, or selective median lobe anatomical endoscopic enucleation according to the treating surgeon's routine clinical judgment.
The study will evaluate whether preoperative urology-based variables can predict 12-month clinical failure. Candidate predictors include intravesical prostatic protrusion length or grade, cystoscopic median lobe morphology, lateral lobe obstruction score, bladder neck configuration, baseline symptom burden, storage symptom burden, uroflowmetry pattern, Qmax, and postvoid residual volume. Intraoperative variables, including procedure type, energy platform, extent of lateral lobe treatment, bladder neck management, operative time, tissue weight, catheter duration, and complications will also be recorded.
The primary endpoint is 12-month composite clinical failure, defined by inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication, recurrent urinary retention or need for recatheterization after the early postoperative period, need for reintervention, or patient-reported global failure due to insufficient urinary benefit.
Secondary outcomes include changes in IPSS, quality of life, uroflowmetry parameters, postvoid residual volume, durability of response, medication-free survival, reintervention-free survival, preservation of antegrade ejaculation, de novo ejaculatory dysfunction, urinary incontinence, urethral stricture, bladder neck contracture, and Clavien-Dindo complications.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 45 years or older.
- •Moderate-to-severe lower urinary tract symptoms due to benign prostatic obstruction or urinary retention requiring transurethral surgery.
- •Preoperative findings suggesting median lobe-dominant or median lobe-related obstruction.
- •Planned selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care.
- •Available baseline International Prostate Symptom Score, uroflowmetry and/or postvoid residual volume, prostate volume, intravesical prostatic protrusion measurement, and cystoscopic assessment.
- •Ability to provide written informed consent and comply with the follow-up schedule.
排除标准
- •Previous prostate surgery for benign prostatic hyperplasia.
- •Known urethral stricture requiring treatment before or during the index procedure.
- •Known neurogenic lower urinary tract dysfunction.
- •Active prostate cancer or bladder cancer requiring treatment that may confound urinary outcomes.
- •Planned complete TURP, complete HoLEP/AEEP, or lateral lobe-dominant surgery.
- •Severe kissing lateral lobe obstruction considered to require complete surgery rather than selective median lobe surgery.
- •Inability to provide valid baseline or follow-up outcome data.
研究组 & 干预措施
Selective Median Lobe TURP
Men undergoing selective transurethral resection of the median lobe for benign prostatic obstruction as part of routine clinical care, without planned complete lateral lobe resection.
干预措施: Selective Median Lobe TURP (Procedure)
Selective Median Lobe HoLEP/AEEP
Men undergoing selective median lobe holmium laser enucleation or another anatomical endoscopic enucleation technique for benign prostatic obstruction as part of routine clinical care, without planned complete gland enucleation.
干预措施: Selective Median Lobe HoLEP/AEEP (Procedure)
结局指标
主要结局
Proportion of Participants With Composite Clinical Failure at 12 Months
时间窗: 12 months after surgery
Composite clinical failure is defined as the presence of at least one of the following within 12 months or at the 12-month assessment: inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication due to recurrent or persistent voiding symptoms, recurrent urinary retention or need for recatheterization after the early postoperative period, need for reintervention, or patient-reported global failure due to insufficient urinary benefit.
次要结局
- Change in International Prostate Symptom Score Total Score(Baseline, 3 months, 6 months, 12 months, and 24 months after surgery)
- Change in International Prostate Symptom Score Voiding Subscore(Baseline, 3 months, 6 months, 12 months, and 24 months after surgery)
- Change in International Prostate Symptom Score Storage Subscore(Baseline, 3 months, 6 months, 12 months, and 24 months after surgery)
- Change in International Prostate Symptom Score Quality of Life Score(Baseline, 3 months, 6 months, 12 months, and 24 months after surgery)
- Change in Maximum Urinary Flow Rate(Baseline, 3 months, 12 months, and 24 months after surgery)
- Change in Postvoid Residual Volume(Baseline, 3 months, 12 months, and 24 months after surgery)
- Proportion of Participants Restarting BPH-Related Medication(Up to 24 months after surgery)
- Proportion of Participants Requiring BPH-Related Reintervention(Up to 24 months after surgery)
- Proportion of Participants With Preserved Antegrade Ejaculation(3 months, 12 months, and 24 months after surgery)
- Proportion of Participants With De Novo Ejaculatory Dysfunction(3 months, 12 months, and 24 months after surgery)
- Proportion of Participants With Postoperative Adverse Events or Late Anatomical Complications(Up to 24 months after surgery)
研究者
Selim Soyturk
Urologist / Coordinating Investigator
Necmettin Erbakan University