Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score
研究概览
简要总结
Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
详细描述
Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
- •IPSS score of ≥
- •Qmax: Peak flow rate ≤ 15 ml/sec.
- •Post-void residual (PVR) < 300 ml.
- •Prostate transverse diameter > 30 mm.
- •Prostate volume between 20 to 120 gm.
- •Voided volume ≥ 125 ml.
- •Subject able to complete the study protocol in the opinion of the Principal Investigator.
- •Subject must be willing to undergo the procedure without anesthesia.
排除标准
- •History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
- •Presence of a penile implant.
- •Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
- •Currently enrolled in another clinical trial.
- •Confirmed or suspected malignancy of prostate or bladder.
- •Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
- •Previous pelvic irradiation or radical pelvic surgery.
- •Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen).
- •Neurogenic bladder or sphincter abnormalities.
- •Urethral strictures, bladder neck contracture or muscle spasms.
- •Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
- •Subjects who are interested in maintaining fertility.
- •Use of concomitant (or recent) medications to include the following:
- •Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).
- •Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
- •5-alpha reductase inhibitor within the last 6 months
- •Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.
- •Subject has chronic urinary retention.
- •Significant urge incontinence.
- •Poor detrusor muscle function.
- •Neurological disorders which might affect bladder or sphincter function.
- •Bladder stones.
- •Renal impairment.
- •In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.
- •Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
- •Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
- •Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
- •Biopsy of the prostate within 30 days prior to the Rezūm procedure.
结局指标
主要结局
Change in International Prostate Symptom Score
时间窗: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure.
次要结局
未报告次要终点