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PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Sponsor: The Netherlands Cancer Institute
Summary
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.
Official title: PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)
Key Details
Gender
MALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
198
Start Date
2024-01-15
Completion Date
2027-01-01
Last Updated
2025-03-13
Healthy Volunteers
No
Interventions
Sildenafil
Taken daily or on demand. First two weeks dosage of 75mg to manage side effects. If side effects are bearable, dosage will be adjusted to 100mg
Erectile vacuum device
5 days a week, generating 5 erections per day
Locations (3)
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Maasstad ziekenhuis
Rotterdam, South Holland, Netherlands