PEnile ReHAbilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicenter, Randomized Clinical Trial
- Conditions
- Erectile dysfunction after prostatecancerimpotence10013356
- Registration Number
- NL-OMON56218
- Lead Sponsor
- rologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
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
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 or
myocardial infarction
* Patients with diseases that affect blood clotting or causes bleeding (i.e.
coagulation disorders) or prolonged
erections
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is an adequate, unassisted erection at 24 months after<br /><br>surgery. In this, an adequate unassisted erection is defined as an erection<br /><br>sufficient for successful sexual intercourse without the use of medication or<br /><br>devices. Measured by IIEF-EF>/=22 after a one-month drug washout or<br /><br>EPIC-erection score (sum off Q8b, 9 and 10) >=83 for patients who did not<br /><br>participate in penetrative sex. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include erectile function (assisted, unassisted, time to<br /><br>recovery, penile length), health and sexual quality of life (other sexual<br /><br>functions, climacturia, feelings of masculinity, health related quality of life<br /><br>of both patients and partners, partner interaction from both perspectives and<br /><br>differences between hetero versus gay/bisexual patients during follow-up),<br /><br>Adherence and side-effects and comparing two sexual function questionnaires. </p><br>