PEHAB II
- Conditions
- Prostate cancerTherapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
Pre-screening eligibility criteria: Age > 18 years and < 75 years, Pre-screening eligibility criteria: Motivated to participate in a penile rehabilitation program, 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., Pre-screening eligibility criteria: Patients who have a penis that has developed naturally, without surgical interventions., 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 blood samples 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, Pre-screening eligibility criteria: Histologically confirmed PCa, Pre-screening eligibility criteria: Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure., Pre-screening eligibility criteria: Non-metastatic disease (cN0M0), Pre-screening eligibility criteria: Pre-operative erections good enough for intercourse (anamnestic)
Adjuvant radiotherapy or hormonal therapy, Inability to use VED such as severe penile deformity or too much peripubic, or belly fat causing fitting problems, All of the above-mentioned pre-screening exclusion criteria, 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, Pre-screening exclusion criteria: 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 pressure. ?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 erections, Pre-screening exclusion criteria: 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 ?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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method