Tests sildenafil and a vacuum device for erectile problems after prostate surgery
Compares daily sildenafil with a vacuum device against on-demand sildenafil in men.
Plain-language title generated from the registry record
Registry title: PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Key facts
- Where
- Amsterdam, Nijmegen, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06875258, who can take part
Where in Netherlands
- Antoni van Leeuwenhoek hospital, Netherlands Cancer InstituteAmsterdam, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsNot yet recruiting
- Maasstad ZiekenhuisRotterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT06875258
- Record updated
- 13 March 2025
- Original description
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.Read full original descriptionShow less
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.
Inclusion: Pre-screening eligibility criteria; Age > 18 years and < 70 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; 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 Fascia Preservation (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, hemoglobin 1Ac, liver enzymes and lipid profile; Testosterone levels of at least >=12 nmol/l, measured pre or post-operative; A signed informed consent form.
Exclusion: Previous pelvic radiation therapy; Patients on Androgen Deprivation Therapy (ADT); 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; Adjuvant radiotherapy or hormonal therapy; Regarding history of oncological treatment; 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 recent 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 transient ischemic attack (TIA), Cerebrovascular accident(CVA), Parkinson, and polyneuropathy; Allergy regarding Sildenafil; 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); Pre-screening exclusion criteria:; Patients with hypotension (blood pressure <90/50 mmHg); Patients using alpha-blockers, but they may be eligible to participate after discontinuing alpha-blocker use; The inability to speak and read in Dutch; 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; >pT3b; Inability to use VED such as severe penile deformity causing fitting problems.