Penile rehabilitation after nerve-sparing prostate surgery
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)
This study is testing two different ways to help men with erectile dysfunction recover after prostate surgery to see which method works better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Nijmegen, Gelderland and 2 other locations) |
| Trial ID | NCT06875258 on ClinicalTrials.gov |
What this trial studies
The PEHAB-II study is a prospective, randomized trial aimed at evaluating the effectiveness of two rehabilitation strategies for erectile dysfunction following nerve-sparing radical prostatectomy in prostate cancer patients. Participants will be assigned to either a combination of daily Sildenafil and vacuum device therapy or standard on-demand Sildenafil treatment. The study will measure the recovery of erectile function over a 24-month period, focusing on achieving unassisted erections sufficient for sexual intercourse. Conducted across multiple centers in the Netherlands, this trial seeks to clarify the best approach for penile rehabilitation post-surgery.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 70 with a confirmed diagnosis of non-metastatic prostate cancer who are scheduled for nerve-sparing radical prostatectomy.
Not a fit: Patients who have not experienced adequate pre-operative erections or those with extensive surgical history affecting penile function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve erectile function recovery and quality of life for patients after prostate cancer surgery.
How similar studies have performed: Previous studies have indicated potential benefits of penile rehabilitation strategies, but this specific approach is novel and aims to provide clearer evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 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 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 Criteria: 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 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 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 * 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 * \>pT3b * Adjuvant radiotherapy or hormonal therapy * Inability to use VED such as severe penile deformity causing fitting problems
Where this trial is running
Nijmegen, Gelderland and 2 other locations
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Gelderland, Netherlands (Not_yet_recruiting)
- Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands (Recruiting)
- Maasstad ziekenhuis — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Melianthe Nicolai, MD/PhD — NCI-Antoni van Leeuwenhoek hospital
- Study coordinator: Inge Cox, MD
- Email: i.cox@nki.nl
- Phone: 020 - 512 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.