Penile rehabilitation after nerve-sparing prostate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute
  Amsterdam, North Holland, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Gelderland, Netherlands Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Platelet-Rich Plasma for Erectile Dysfunction After Prostate Surgery

  This trial tests whether injecting a patient’s own platelet-rich plasma can improve erectile function in men who have persistent ED more than a year after nerve-sparing radical prostatectomy.

  Recruiting Herlev and Gentofte Hospital · Herlev · NCT07863388

• Tractography-Guided Nerve-Sparing in Prostate Cancer

  A nerve-sparing approach during prostate cancer surgery uses 3D nerve maps created from diffusion tensor imaging to guide the surgeon and see if preservation of nerves improves function.

  Recruiting University Hospital, Geneva · Geneva, Canton of Geneva · NCT07847385

• Impact of an accessory pudendal artery on erection recovery after nerve-sparing prostate surgery

  This study checks if preserving an extra artery (the accessory pudendal artery) during robotic prostate removal helps men regain erections after nerve-sparing surgery.

  Recruiting University College, London · London · NCT07597798

• Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Prostate Surgery

  This trial tests a virtual, self-directed program before and after robot-assisted prostate surgery to help men regain erectile function and urinary continence.

  Recruiting at 2 sites Phase 2 Surgical Outcomes Research Centre (SOuRCe) · Sydney, New South Wales and 2 other locations · NCT07576335

• Mobile perioperative education with video pelvic floor training after radical prostatectomy

  This test checks whether a smartphone app that provides perioperative education, reminders, and video-guided pelvic floor exercises helps men undergoing radical prostatectomy have less urinary leakage and better erectile function.

  Recruiting Giresun University · Giresun, Giresun · NCT07520916

• New nerve surgery to help men regain erections after prostate cancer surgery

  This study will try a new nerve graft surgery using the ilioinguinal nerve to help men who lost erections after prostate removal regain erectile function within a year.

  Recruiting Sir Mortimer B. Davis - Jewish General Hospital · Montreal, Quebec · NCT07188064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.