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RECRUITING
NCT06875258
PHASE4

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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

DRUG

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

DEVICE

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