Erectile Dysfunction, Prostatic Neoplasms, Urinary Incontinence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPreservation (endopelvic fascia)
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
PROCEDUREOpening (endopelvic fascia)
Robotic assisted radical prostatectomy with opening of endopelvic fascia
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Localized prostate cancer * Planned nerve-sparing robotic radical prostatectomy * Gleason score 7 or less
Exclusion criteria
* Previous prostate surgery (TURP, TUIP, laser...) * Planned lymphadenectomy * T3 cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary incontinence | 1 year | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery |
| Erectile function | 1 year | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 year | Clavien-Dindo classification |
| Oncologic results: positive surgical margin rate | 1 year | Positive surgical margin rate as reported in pathological analysis of the removed prostate |
Countries
Finland
Outcome results
None listed