This study aims to assess the effect of two different rehabilitation strategies on the recovery rate of ED after nsRP in patients who undergo nsRP.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Postoperative erectile dysfunction (ED) is a widely observed side effect of
prostate cancer surgery for clinically localized prostate cancer and it has a
substantial impact on the quality of life. While nerve-sparing radical
prostatectomy (nsRP) has improved the outcomes of erectile function, ED rates
remain high even after well-performed nsRP. It is important to note that ED
after nsRP is not primarily caused by complete transection (neurotmesis) but
rather by neuronal crushing and/or overstretching (neuropraxia) of the
neurovascular bundle running alongside the prostate towards the erectile tissue
of the penis. It is suggested that the post-operative care is insufficient to
consolidate the effects of nsRP because penile rehabilitation is necessary to
activate neural recovery as well as to retain the vasculogenic functions of the
penile corpora cavernosa. However, the best penile rehabilitation strategy to
reduce post-operative ED remains unclear due to a lack of well-designed
randomized studies.
Study objective
This study aims to assess the effect of two different rehabilitation strategies
on the recovery rate of ED after nsRP in patients who undergo nsRP.
Study design
This study is a multicentre, randomized, controlled clinical trial.
Intervention
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.
Study burden and risks
In this study, patients will be evaluated at baseline and every three months
thereafter through telephonic appointments, online surveys, and outpatient
clinic visits. These outpatient clinic visits will take 20 minutes on average.
Patients and partners will fill out HRQoL questionnaires and questionnaires on
sexual functioning online. In order to answer these questions correctly,
patients and partners will be advised to participate in sexual activity at
least once a month. Answering the questionnaires will take approximately 20
minutes. for patients and 10 minutes for partners. In addition, patients will
be asked to provide blood samples once at baseline, to determine testosterone
levels, HbA1c, liver enzymes, and lipid profiles. Patients may experience side
effects from sildenafil (such as dyspepsia, dizziness, and headache) or the VED
(i.e. cold feeling, pain, hematoma, or oedema). These effects are temporary and
subside within 25 hours. Participating patients in both arms benefit from free
sildenafil and VED, along with the extra attention and guidance provided for
sexual recovery, sexual health and erectile function compared to patients that
do not participate in the study.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
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
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84375.041.23 |