NCT02943070已完成不适用
NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- International Prostate Symptom Score (IPSS) Change From Baseline
研究概览
简要总结
Evaluate the safety and efficacy of the Rezum System for the treatment of BPH
详细描述
Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.
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 investigator.
- •Life expectancy of at least one year.
排除标准
- •History of any illness or surgery that may confound the results of the study or have risk to subject.
- •Presence of a penile implant.
- •Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
- •Currently enrolled or has been enrolled in another trial in the past 30 days.
- •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 catherization specimen)
- •Neurogenic bladder or sphincter abnormalities.
- •Urethral strictures, bladder neck contracture or muscle spasms.
- •Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)
- •Subjects interested in maintaining fertility.
- •Use of concomitant medications to include the following:
- •Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
- •Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
- •Use of 5-alpha reductase inhibitor within the last 6 months
- •Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
- •Subject is unable or unwilling to go through the "washout" period prior to treatment.
- •Subject has chronic urinary retention.
- •Post-void residual volume > 300 ml.
- •Significant urge incontinence.
- •Poor detrusor muscle function.
- •Neurological disorders which might affect bladder or sphincter function.
- •Urinary sphincter abnormalities.
- •Bladder stones.
- •Evidence of bacterial prostatitis or symptoms of epididymitis
- •Renal impairment or serum creatinine > 2.0 mg/dl
- •In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
- •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 direct and accurate communication with the study investigator regarding the study.
- •Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
- •Biopsy of prostate within 30 days of procedure.
结局指标
主要结局
International Prostate Symptom Score (IPSS) Change From Baseline
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 (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Major Complications
时间窗: 3 months
Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation
次要结局
- Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Change in Sexual Function - Erectile Function(1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Procedural Pain Score(Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure)
- Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)(1 month, 3 months, 6 months, 1 year, then annually to 5 years)
- Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years)
- Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)(Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years)
- Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family(1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years)
- Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L(1 month, 3 months, 6 months, 1 year, then annually to 5 years)
- Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L(1 month, 3 months, 6 months, 1 year, then annually to 5 years)
- Subject Satisfaction - Satisfied With Overall Procedure(1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years)
- Procedural Parameters - Treatment Time(Day of Procedure)
- Change in Sexual Function - Retrograde Ejaculation(1 Week post procedure, 1 Month post procedure, 3 Months post procedure)
- International Prostate Symptom Score (IPSS) Assessment by Prostate Volume(Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years)
- Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years(1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years)
- Procedural Parameters - Procedure Time(Day of Procedure)
研究者
研究点 (3)
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