RBR-1094jttz招募中3 期
Prospective, randomized study of Prostatic Urethral Lift versus Combined Pharmacological Therapy for men with LUTS-BPH - CombLIFT Combined pharmacological therapy vs Lift of prostatic urethral
niversidade de São Paulo0 个研究点开始时间: 2023年5月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50Y 至 0（—）
- 性别
- Male
入选标准
- •Men aged > 50 years, with symptomatic prostate hyperplasia and willing to undergo treatment; International Prostate Symptom Score IPSS = 13; Peak urine flow rate = 12ml/s in a urine volume = 125ml; Prostate volume = 40 cc and = 100 cc and prostatic length = 40 mm and = 100 mm assessed by transabdominal prostate ultrasound
排除标准
- •Current urinary retention; Post voiding residue > 250ml; Prostate protrusion index (PPI) = 1cm on transabdominal prostate ultrasound;. Active urinary tract infection at the time of treatment; Procedure for treating previous BPH; Urethral conditions that may prevent insertion and release of the device into the bladder (urethral stenosis, meatus stenosis, bladder neck contracture); Previous pelvic surgery or irradiation; History of neurogenic or atonic bladder; Urinary incontinence; Prostate biopsy within the last 6 weeks; Estimated life expectancy of less than 1 year;;History of prostate or bladder cancer;; PSA > 10ng/ml unless prostate biopsy is negative for cancer; Current macroscopic hematuria; Serum creatinine > 1.8mg/dl or upper tract disease that compromises renal function; Known coagulopathies or use of anticoagulants or antiplatelet agents other than aspirin = 10 mg (unless antiplatelet agents are suspended at least 3 days before the procedure); Use within 4 months of baseline assessment: estrogen, any androgen-suppressing medication, or anabolic steroids.Within 3 months of baseline assessment: 5-alpha-reductase inhibitor; Within 2 weeks of the initial assessment; Alpha-blockers, androgens, gonadotropin releasers, hormone analogues, anticholinergics or cholinergic medication; Medications with phenylephrine, pseudoephedrine or imipramine; Within 6 months of baseline: combination therapy with 5-alpha-reductase inhibitor and alpha-blockers; Within 1 week of baseline, unless documented stable dose for = 6 months: beta-blockers, antidepressants, anticonvulsants, and antispasmodics;Cystolithiasis in the last 3 months;History of prostatitis requiring treatment (antibiotics) in the last year; Other comorbidities that may impact the outcome of the study, such as: severe cardiac arrhythmias not controlled by medication or a pacemaker, congestive heart failure NYHA III or IV, history of uncontrolled diabetes mellitus, significant respiratory disease in which hospitalization may if necessary, known immunosuppression (AIDS, post-transplant, in chemotherapy); Unable or unwilling to complete all required questionnaires and follow-up assessments; Unable or unwilling to sign the informed consent form; Currently enrolled in any other experimental clinical research trials that have not completed the primary endpoint
研究者
相似试验
进行中（未招募）
不适用
Partial prostate Ablation versus Radical Treatment (PART): Comparing partial ablation of the prostate to treatment or removal of the whole prostate in men with localised cancer of one side of the prostate onlyCancerProstate cancerISRCTN17249875niversity of Oxford800
尚未招募
2 期
A randomised clinical trial comparing post-operative pain scores in patients with suspected prostate cancer undergoing transperineal prostate biopsy with and without a periprostatic nerve block under general anaesthesia.transperineal prostate biopsypost-operative painCancer - ProstateSurgery - Surgical techniquesAnaesthesiology - Pain managementprostate cancerACTRN12621001143819Chris O Brien Lifehouse50
已完成
不适用
European Randomised study of Screening for Prostate CancerProstate cancerCancerISRCTN49127736Erasmus Medical Centre (Netherlands)251,133
进行中（未招募）
不适用
A Clinical Phase II Study in Patients with Prostate Cancer and Bone Metastases with KML001 (KOMINOX®) - KML001 in patients with prostate cancer and bone metastasesProstate Cancer MetastaticMedDRA version: 8.1Level: LLTClassification code 10036909Term: Prostate cancer metastaticEUCTR2006-005607-33-DEKOMINOX USA, Inc.
尚未招募
不适用
Clinical efficacy and safety of prostatic periapical triangle block for transperineal cognitive fusion prostate biopsy and rectal hydrogel spacer injection.prostate cancerJPRN-UMIN000041610Department of Urology, Saitama Medical Center, Saitama Medical University190