Prostatic NeoplasmsNCT02526602
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
A study testing Preservation (endopelvic fascia) and Opening (endopelvic fascia) in people with Prostatic Neoplasms and Urinary Incontinence, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction
- What is being tested?
- Preservation (endopelvic fascia) and Opening (endopelvic fascia)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2015to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized prostate cancer
- Planned nerve-sparing robotic radical prostatectomy
- Gleason score 7 or less
Who cannot join
- Previous prostate surgery (TURP, TUIP, laser...)
- Planned lymphadenectomy
- T3 cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
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.
Read the 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.
- Being tested
- Preservation (endopelvic fascia), Opening (endopelvic fascia)
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservation (endopelvic fascia)Procedure or surgery
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
Opening (endopelvic fascia)Procedure or surgery
Robotic assisted radical prostatectomy with opening of endopelvic fascia
| Study group | Role | What they receive |
|---|---|---|
| Preservation (endopelvic fascia) | Experimental | During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved. Receives: Procedure: Preservation (endopelvic fascia) |
| Opening (endopelvic fascia) | Active comparator | During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened. Receives: Procedure: Opening (endopelvic fascia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Measured: 1 year
Erectile function
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Measured: 1 year
Secondary outcomes (2)
Complications
Clavien-Dindo classification
Measured: 1 year
Oncologic results: positive surgical margin rate
Positive surgical margin rate as reported in pathological analysis of the removed prostate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jarno Riikonen, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526602
- Sponsor's protocol ID
- R15043
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2015
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siltari A, Riikonen J, Murtola TJ. Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Sexual Function - A Randomized Clinical Trial. J Sex Med. 2021 Feb;18(2):327-338. doi: 10.1016/j.jsxm.2020.11.003. Epub 2020 Dec 23.
PubMed 33358241
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02526602
- Acronym / sponsor ID
- R15043
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservation (endopelvic fascia) | Experimental | Procedure: Preservation (endopelvic fascia)During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved. |
| Opening (endopelvic fascia) | Active comparator | Procedure: Opening (endopelvic fascia)During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Localized prostate cancer
- Planned nerve-sparing robotic radical prostatectomy
- Gleason score 7 or less
Key exclusion criteria (3 listed)
- Previous prostate surgery (TURP, TUIP, laser...)
- Planned lymphadenectomy
- T3 cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservation (endopelvic fascia)Robotic assisted radical prostatectomy with preserving of endopelvic fascia | Procedure or surgery | Preservation (endopelvic fascia) |
| Opening (endopelvic fascia)Robotic assisted radical prostatectomy with opening of endopelvic fascia | Procedure or surgery | Opening (endopelvic fascia) |
Primary outcome
Urinary incontinence
Time frame: 1 year
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Erectile function
Time frame: 1 year
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
2 secondary outcomes
Complications
Time frame: 1 year
Oncologic results: positive surgical margin rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 33358241Siltari A, Riikonen J, Murtola TJ. Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Sexual Function - A Randomized Clinical Trial. J Sex Med. 2021 Feb;18(2):327-338. doi: 10.1016/j.jsxm.2020.11.003. Epub 2020 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarno Riikonen, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservation (endopelvic fascia) and Opening (endopelvic fascia) in people with Prostatic Neoplasms and Urinary Incontinence, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.