Erectile dysfunction after prostatecancer impotence impotence
Conditions
Interventions
Patients will be randomized 1:1: to arm 1: High intensive therapy using a daily 
dose of 75/100 mg Sildenafil for 12 month, combined with vacuum device (VED) 
therapy for 10 minutes a day, five times a week
or to arm 2: Less intensive 
therapy using 75/100mg Sildenafil on demand (before sexual activity). After 
these 12 months in therapy, the treatment intensity can be adjusted for the 
next 12 month until the full neuropraxia recovery time (24 month) has been 
reached. The treatment option that can be used to intensify the therapy is 
intracavernosal injection therapy (ICI), in which erections can be obtained 
quickly by injecting papaverine/phentholamine (Androskat) in the penis. This 
auxiliary therapy can be an option for those that do not want to wait any 
longer for the recovery of their spontaneous erections and thus that want to 
use ICI to obtain erections in the meantime. It is important to note that ICI 
is not a part of the rehabilitation program and thus is not mandatory. Patients 
will finish participating in the trial after 24 months follow-up. One month 
before end of follow-up (23 months) a drug washout will take place. 
Endpoints will be assessed after 24 months using validated questionnaires as 
well and composed validated questions.
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pre-screening eligibility criteria * Age > 18 years and 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
Exclusion criteria
Exclusion criteria: 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 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 (CVA or TIA) or myocardial infarction * Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections*Patients with a severe renal impairment (creatinine clearance <30 mL/min) *Patients with hepatic impairment (cirrhosis) Other pre-screening exclusion criteria: * Patients with other neurological diseases; such as 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 problem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is an adequate, unassisted erection at 24 months after surgery. In this, an adequate unassisted erection is defined as an erection sufficient for successful sexual intercourse without the use of medication or devices. Measured by IIEF-EF>/=22 after a one-month drug washout or EPIC-erection score (sum off Q8b, 9 and 10) >=83 for patients who did not participate in penetrative sex. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include erectile function (assisted, unassisted, time to recovery, penile length), health and sexual quality of life (other sexual functions, climacturia, feelings of masculinity, health related quality of life of both patients and partners, partner interaction from both perspectives and differences between hetero versus gay/bisexual patients during follow-up), Adherence and side-effects and comparing two sexual function questionnaires. | — |
Countries
Netherlands
Contacts
Public ContactM. P. J. Nicolai
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed