NL-OMON56218招募中不适用
PEnile ReHAbilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicenter, Randomized Clinical Trial - PEHAB-II Trial
rologie0 个研究点目标入组 220 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
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
- 18 至 99（—）
入选标准
- •Pre-screening eligibility criteria
- •* Age > 18 years and < 75 years
- •* Patients who have a penis that has developed naturally, without surgical
- •interventions.
- •* Histologically confirmed PCa
- •* Scheduled for RP as primary treatment with the intention of at least a
- •one-sided nerve-sparing procedure.
- •* Non-metastatic disease (cN0M0)
- •* Pre-operative erections good enough for intercourse (anamnestic)
- •* Motivated to participate in a penile rehabilitation program
- •Inclusion criteria
- •To be eligible to participate in this study, a subject must meet all of the
- •following post- operative criteria:
- •* All of the above-mentioned pre-screening eligibility criteria
- •* At least unilateral nerve-sparing or if available FP score =>5
- •* A pre-diagnostic anamnestic erection that was good enough for intercourse.
- •* A pre-diagnostic IIEF-EF>=22 with or without PDE5i. For patients without a
- •partner or did not participate in
- •penetrative sex we use accumulated score of EPIC- erectile function; Q8b, Q9
- •and Q10 >=83.
- •* Willing to provide one blood sample to determine testosterone level, Hb1Ac,
- •liver enzymes and lipid profile
- •* Testosterone levels of at least >9 nmol/l, measured pre or post-operative,
- •blood needs to be obtained before 11 am and before breakfast with the absence
- •of hypo gonadal symptoms such as loss of libido, lack of energy and orgasmic
- •dysfunction.
- •* A signed informed consent form
排除标准
- •6.3 Pre-screening exclusion criteria:
- •Regarding history of oncological treatment
- •* Previous pelvic radiation therapy
- •* Patients on Androgen Deprivation Therapy (ADT)
- •* Patients with diseases that affect the red blood cells (e.g., sickle cell
- •anaemia), blood cancer (leukaemia) or
- •bone marrow tumors
- •Regarding history of cardiovascular diseases
- •* Patients with heart failure New York Heart Association (NYHA) >= class 3
- •* Patients with increased susceptibility to vasodilators include those with
- •left ventricular outflow obstruction
- •(e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with
- •the rare syndrome of multiple
- •system atrophy manifesting as severely impaired autonomic control of blood
- •* Patients with unstable angina pectoris
- •* Patients using nitride oxide for coronary artery disease
- •* Patients with hypotension (blood pressure <90/50 mmHg)
- •* Patients with recent (within the last 6 months) history of stroke or
- •myocardial infarction
- •* Patients with diseases that affect blood clotting or causes bleeding (i.e.
- •coagulation disorders) or prolonged
- •Other pre-screening exclusion criteria:
- •* Patients with neurological diseases; such as CVA, TIA, Parkinson, and
- •polyneuropathy.
- •* Allergy regarding Sildenafil
- •* Patients who have loss of vision in one eye because of non-arteritic anterior
- •ischaemic optic neuropathy
- •(NAION), regardless of whether this episode was in connection or not with
- •previous PDE5 inhibitor exposure.
- •* Patients with severe hepatic impairment (based on blood test)
- •* Patients with known hereditary degenerative retinal disorders such as
- •retinitis pigmentosa (a minority of
- •these patients have genetic disorders of retinal phosphodiesterases).
- •* Patients using alpha-blockers, but they may be eligible to participate after
- •discontinuing alpha-blocker use.
- •* The inability to speak and read in Dutch
- •Exclusion criteria
- •* A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •* All of the above-mentioned pre-screening exclusion criteria
- •* Adjuvant radiotherapy or hormonal therapy
- •* Inability to use VED such as severe penile deformity or too much peripubic,
- •or belly fat causing fitting problems
研究者
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