Urinary Incontinence Clinical Trial
Official title:
Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
NCT number | NCT02526602 |
Other study ID # | R15043 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | September 2019 |
Verified date | September 2019 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 158 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary incontinence | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery | 1 year | |
Primary | Erectile function | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery | 1 year | |
Secondary | Complications | Clavien-Dindo classification | 1 year | |
Secondary | Oncologic results: positive surgical margin rate | Positive surgical margin rate as reported in pathological analysis of the removed prostate | 1 year |
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