Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostatic Median Lobe for the Treatment of Benign Prostatic Hyperplasia in Men With Prominent Median Lobe Desiring Preservation of Ejaculation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
研究概览
简要总结
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.
详细描述
Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients must be 45 years of age or older
- •Patients must be diagnosed with benign prostatic hyperplasia
- •Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
- •Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy
排除标准
- •Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score < 15
- •Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- •Patients with prostate glands greater or equal to 100 grams
- •Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
- •Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
结局指标
主要结局
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
时间窗: Up to 12 months
To evaluate improvement of symptoms through the International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months. The IPSS is an 8-question screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Scoring: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
次要结局
- Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).(Up to 12 months)
- Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).(Up to 12 months)
- Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).(Up to 12 months)
- Post-Operative measurement of Peak Urine Flow Rate (Qmax)(Up to 12 months)
- Post-Operative measurement of Post Void Residual (PVR)(Up to 12 months)
研究者
Don Neff, MD, FACS
Principle Investigator
University of Kansas Medical Center