Actively Recruiting
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Led by The Netherlands Cancer Institute · Updated on 2025-03-13
198
Participants Needed
3
Research Sites
154 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
A
Antoni van Leeuwenhoek Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18 years and younger than 70 years
- Natural penis development without surgical interventions
- Histologically confirmed prostate cancer
- Scheduled for radical prostatectomy with at least unilateral nerve-sparing procedure
- Non-metastatic disease (clinical stage cN0M0)
- Good pre-operative erections sufficient for intercourse
- Motivated to join a penile rehabilitation program
- Post-operative criteria include at least unilateral nerve-sparing or Fascia Preservation score ≥5
- Pre-diagnostic erection function score IIEF-EF ≥22 or EPIC erectile function score ≥83 if no penetrative sex
- Willing to provide one blood sample for hormone and blood tests
- Testosterone level at least ≥12 nmol/l measured before or after surgery
- Signed informed consent form
You will not qualify if you...
- Previous pelvic radiation therapy
- Current androgen deprivation therapy
- Blood diseases affecting red blood cells or bone marrow tumors
- Heart failure NYHA class 3 or higher
- Increased risk from vasodilators due to heart conditions like aortic stenosis or hypertrophic cardiomyopathy
- Unstable angina pectoris
- Use of nitride oxide for coronary artery disease
- Low blood pressure (below 90/50 mmHg)
- Recent stroke or heart attack
- Blood clotting disorders or prolonged erections
- Neurological diseases such as transient ischemic attack, stroke, Parkinson's, or polyneuropathy
- Allergy to Sildenafil
- Vision loss in one eye from non-arteritic anterior ischemic optic neuropathy
- Severe liver impairment
- Known hereditary retinal degenerative disorders like retinitis pigmentosa
- Use of alpha-blockers unless discontinued before participation
- Inability to speak or read Dutch
- Pathological stage above pT3b
- Receiving adjuvant radiotherapy or hormonal therapy
- Severe penile deformity preventing use of vacuum erection device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532SZ
Not Yet Recruiting
2
Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
3
Maasstad ziekenhuis
Rotterdam, South Holland, Netherlands, 3079DZ
Not Yet Recruiting
Research Team
I
Inge Cox, MD
CONTACT
M
Melianthe Nicolai, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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