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New treatment option for Erectile Dysfunction Following Radical Prostatectomy
Official title PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
ClinicalTrials.gov ID: NCT06875258
What this study is testing
What is Sildenafil?
Sildenafil is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for erectile dysfunction following radical prostatectomy.
Also referred to as Mylan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, men only
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Amsterdam, North Holland, Netherlands
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Amsterdam, North Holland, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.