Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively. Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability. The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.
180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened. After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
158
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
Robotic assisted radical prostatectomy with opening of endopelvic fascia
Tampere University Hospital
Tampere, Finland
Urinary incontinence
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Time frame: 1 year
Erectile function
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Time frame: 1 year
Complications
Clavien-Dindo classification
Time frame: 1 year
Oncologic results: positive surgical margin rate
Positive surgical margin rate as reported in pathological analysis of the removed prostate
Time frame: 1 year
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