Effect of Prostatic Urethral Lift (PUL) Versus Prostate Arterial Embolization (PAE),Novel Minimally Invasive Treatment Options on Health-related Quality of Life (HRQoL) in Men With Lower Urinary Tract Symptoms Secondary to BPH.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improvement in QOL
研究概览
简要总结
For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter. Current medical and surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery times, degradation of sexual function and incontinence may negatively affect a patient's QoL.
Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar safety profiles. More importantly neither causes degradation of sexual function or urinary continence. Although multiple studies are being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from prostate enlargement.
详细描述
As the population ages, there is a growing need to find ways for people to live longer with satisfactory quality of life (QoL), even in the midst of increasing health problems. For the ageing man, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome LUTS attributable to benign prostatic hypertrophy (BPH) and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter.
Current medical and surgical treatments like TURP for BPH offer symptomatic improvement of LUTS but may adversely affect a patient's QOL and satisfaction. Peri-operative complications and long recovery times, degradation of sexual function and iatrogenic incontinence may negatively affect a patient's QoL overall, resulting in patient viewing this as a treatment failure. Therefore when evaluating treatment options for BPH, treatment options with important QOL measures of satisfaction have to be considered.
Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Multiple prospective and retrospective studies have shown that both PUL and PAE yield relief of lower urinary tract symptoms over a period of several weeks. They display similar safety profiles with self-limiting pelvic discomfort characterizing the commonest minor adverse event. Both procedures are minimally invasive and have the potential to be carried out under local anesthesia and in the outpatient setting with suitability for patients with cardiovascular comorbidities. Another important finding is that neither has been found to cause degradation of sexual function.
Although there are an increasing number of data series being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. All the endpoints will be evaluated using validated questionnaires and laboratory values. Results of this study will be transferable to clinical practice and could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from LUTS due to BPH in all practice settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 aged ≥40 yr Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study Diagnosis of urinary symptoms (LUTS) from prostatic enlargement (BPH) refractory to medical therapy for at least 6 months.
- •International Prostate Symptom Score >12
排除标准
- •Active urinary tract infections, prostatitis, or interstitial cystitis.
- •Biopsy proven prostate, bladder, or urethral cancer.
- •The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- •Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
- •Patients with baseline PSA levels > 10 ng/mL
- •Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- •Significant median lobe enlargement.
- •Large prostates, volume >80 g.
- •Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.)
- •Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- •Urethral conditions that may prevent insertion of a rigid 20F cystoscope
- •Current urinary retention.
- •Acontractile detrusor.
- •Current gross hematuria
- •Known upper tract renal disease
- •Cystolithiasis
- •ASA > 3 or severe medical debilitating condition
- •History of pelvic irradiation or radical pelvic surgery
- •Known allergy to nickel.
- •Active urinary tract infections, prostatitis, or interstitial cystitis.
- •Biopsy proven prostate, bladder, or urethral cancer.
- •The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- •Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
- •Patients with baseline PSA levels > 10 ng/mL
- •Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- •Unable to have CT angio of the prostate imaging
- •Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.)
- •Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- •Acontractile detrusor.
- •Known upper tract renal disease
- •Cystolithiasis
- •Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. Known major iliac arterial occlusive disease
- •ASA > 3 or severe medical debilitating condition
- •Baseline serum creatinine level > 1.8 mg/dl
- •Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
- •History of pelvic irradiation or radical pelvic surgery
- •Allergy to iodinated contrast agents
研究组 & 干预措施
PAE-Prostate Arterial Embolization
PAE-Prostate Arterial Embolization
干预措施: UroLift as artifical device for prostatic urethral lift. (Device)
PAE-Prostate Arterial Embolization
PAE-Prostate Arterial Embolization
干预措施: Embospheres Microspheres as embolic agents for prostate artery embolization (Device)
PUL- Prostatic urethral lift
PUL- Prostatic urethral lift
干预措施: UroLift as artifical device for prostatic urethral lift. (Device)
PUL- Prostatic urethral lift
PUL- Prostatic urethral lift
干预措施: Embospheres Microspheres as embolic agents for prostate artery embolization (Device)
结局指标
主要结局
Improvement in QOL
时间窗: 3,6,12 months
Improvement in QOL score
次要结局
- Lack of change in urinary incontinence(3,6,12 months)
- Change in Urinary flow after procedure(3,6,12 months)
- Change in Prostate volume after procedure(3,6,12 months)
- Recovery experience(1 day, 8 days and 1 month)
- Lack of change in ejaculation during sex(3,6,12 months)
- Change in residual urine left in bladder after procedure(3,6,12 months)
- Change in Prostatic specific antigen (PSA) after procedure(3,6,12 months)
- Number of patients with clinical adverse events(1 day, 8 days and 1,3,6,12 months)
- Post operative morbidity(1 day, 8 days and 1 month)
- Lack of change in sexual function(3,6,12 months)
- Improvement in symptoms of LUTS(3,6,12 months)
研究者
Keith Pereira, MD:
MD, Assistant professor, Interventional Radiology
St. Louis University