Prostatic CancerNCT04043637
Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks
An observational study of Prostatic Cancer and Surgical Procedure, Unspecified, run by Consorci Sanitari Integral.
Trial summary
This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostatic Cancer, Surgical Procedure, Unspecified, Urinary Incontinence
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2012to 10 Apr 2019
- Phase
- Observational
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical Prostatectomy from 2012 to 2018, always performed by the same surgeon
Who may be able to join
- Age between 40 and 75 years
- A Body Mass Index lower than 35 Hg/m2
- Patients with organ-confined prostate cancer
- Signed informed consent
Who cannot join
- Contraindications for Laparoscopy
About this study
Official title: Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence
This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.
Read the detailed description
This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the proportion of patients with of urinary incontinence
Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy
Measured: The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery
Secondary outcomes (3)
change in the proportion of patients with recovery of the erectile function
assessment of the recovery of the erectile function after surgery
Measured: every month during the first year after surgery
number of patients with overall positive surgical margins
postoperative assessment of positive surgical margins
Measured: immediate postoperative period
biochemical recurrence rate
Measured: until the completion of the study, with a mean follow-up of 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start23 Apr 2012
- Primary completion3 Dec 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043637
- Sponsor's protocol ID
- 19/24
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence
- ClinicalTrials.gov ID
- NCT04043637
- Acronym / sponsor ID
- 19/24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 23 Apr 2012 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- 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.
This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.
Detailed description
This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical Prostatectomy from 2012 to 2018, always performed by the same surgeon
Key inclusion criteria (4 listed)
- Age between 40 and 75 years
- A Body Mass Index lower than 35 Hg/m2
- Patients with organ-confined prostate cancer
- Signed informed consent
Key exclusion criteria (1 listed)
- Contraindications for Laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in the proportion of patients with of urinary incontinence
Time frame: The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery
Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy
3 secondary outcomes
change in the proportion of patients with recovery of the erectile function
Time frame: every month during the first year after surgery
number of patients with overall positive surgical margins
Time frame: immediate postoperative period
biochemical recurrence rate
Time frame: until the completion of the study, with a mean follow-up of 72 months
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 6 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Cancer and Surgical Procedure, Unspecified, run by Consorci Sanitari Integral.
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 4 inclusion and 1 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
change in the proportion of patients with of urinary incontinence (time frame: The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2019.