PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Recruiting
Phase 4
Interventional Study
Erectile Dysfunction Following Radical Prostatectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 198 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This Trial
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: m…
Trial Locations
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Eligibility 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…
Contacts