Prostate CancerNCT05605171
Posterior Urethrovesical Anastomotic Reconstruction in Comparison to Conventional Urethrovesical Anastomosis
A study testing Posterior reconstruction urethrovesical anastomosis. and Conventional vesicourethral anastomosis. in people with Prostate Cancer, run by St. Joseph's Healthcare Hamilton.
Trial summary
Urinary incontinence post radical prostatectomy is a well-recognized complication regardless of approach, with a potential negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in the literature, few patients are continent in the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Posterior reconstruction urethrovesical anastomosis. and Conventional vesicourethral anastomosis.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2014to 23 Mar 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0).
Who cannot join
- History of previous prostatic and/or urethral surgery
- A known history of a disease or comorbidity that could affect continence, such as insulin-dependent diabetes or urethral stenosis
- Presence of a urinary catheter preventing preoperative evaluation of continence.
About this study
Official title: Impact of Posterior Urethrovesical Reconstruction on Early Return to Urinary Continence Following Robot-assisted Radical Prostatectomy: a Prospective Randomized Controlled Trial
Urinary incontinence post radical prostatectomy is a well-recognized complication regardless of approach, with a potential negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in the literature, few patients are continent in the early postoperative period. It has been suggested that posterior reconstruction of the Denonvilliers' musculofascial plate, also known as the Rocco stitch, may improve early return to urinary continence, though clinical equipoise remains.
Read the detailed description
Each modality of prostate cancer treatment has the propensity to lead to negative outcomes on quality of life to varying degrees. It is our responsibility to incorporate into our practices the most beneficial treatment regimens that render patients' cancer-free while minimizing potential treatment-related adverse outcomes, including incontinence and erectile dysfunction. Urinary incontinence and erectile dysfunction are the two most well described complications of radical prostatectomy with observed rates of 8.4% and 59.9%, respectively. Delayed recovery of urinary continence following radical prostatectomy (RP) is a well-known entity. Numerous contributing factors have been identified for post-prostatectomy incontinence (PPI), including both patient (age, body mass index, membranous urethral length, prostate volume, pre-existing lower urinary tract symptoms, and oncologic factors) and surgeon characteristics (experience, technique).
In a systematic review a meta-analysis using a no pad or a single safety pad definition, Ficcara and colleagues showed that the 12-month urinary incontinence rates can range from 8% to 11%. As such, several reconstructive options have been incorporated into the contemporary RP to attempt to improve these outcomes. The anatomy of urethral-sphincteric vesico-prostatic complex is well-described, leading to attempts to perform reconstruction of the Denonvilliers' musculofascial plate during the urethrovesical anastomosis (UVA) at the time of RP. Performing a posterior reconstruction (PR) of the rhabdosphincter was first reported by Rocco et al. in 2006 during open retropubic RP, showing a 3, 30, and 90-day improvement in urinary continence post catheter removal.
Posterior reconstruction urethrovesical anastomosis (PR-UVA) has been hypothesized to improve the integrity of the rhabdosphincter and potentially increase the functional urethral length. However, a recent systematic review evaluating the efficacy of PR-UVA showed no improvement in urinary continence at 1 week and 3, 6, and 12 months. Conflicting studies within the literature render an environment of clinical equipoise in this specific patient-related outcome. Our study objective was to address the true clinical benefit of the PR-UVA in a large prospective randomized controlled trial (RCT).
- Conditions
- Prostate Cancer
- Being tested
- Posterior reconstruction urethrovesical anastomosis., Conventional vesicourethral anastomosis.
- Keywords
- Localized prostate cancer, Robot-assisted laparoscopic radical prostatectomy, Vesicourethral anastomosis, Posterior vesicourethral anastomosis reconstruction, Rocco stitch, Urinary incontinence
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior reconstruction urethrovesical anastomosis.Procedure or surgery
Rocco stitch.
Conventional vesicourethral anastomosis.Procedure or surgery
Standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Posterior reconstruction urethrovesical anastomosis. | Experimental | The intervention comprised of a 2-stitch approximation of the free edge of the Denonvilliers' fascia and posterior bladder wall cranially, to the posterior aspect of the rhabdosphincter and the posterior median raphe caudally, respectively, following prostate extraction. The aim of this approach is to ultimately restore the length of the urethrosphincteric complex, prevent its caudal retraction, and avoid undue tension on the subsequent vesicourethral anastomosis, and provide a posterior support to the urethral sphincter complex to facilitate its effective contraction. Receives: Procedure: Posterior reconstruction urethrovesical anastomosis. |
| Conventional urethrovesical anastomosis. | Active comparator | The conventional is fashioned with a continuous running technique that uses two sutures. The first suture is passed in a clockwise hemicircumferential manner, starting from outside in on the bladder neck at the 5 o'clock position and inside out on the urethra up toward the 12 o'clock position. The second suture is similarly run in a counter- clockwise hemicircumferential direction. The running sutures are snug down after each apposition to ensure there is no slack, and finally tied together with several knots at the 12 o'clock position. Receives: Procedure: Conventional vesicourethral anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to urinary incontinence
The validated EPIC-26 (The Expanded Prostate Cancer Index Composite) Short Form (© The University of Michigan).
Measured: 12 months post procedure
Secondary outcomes (1)
Need for incontinence improving procedure
Midurethral sling or artificial urinary sphincter
Measured: 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start19 Mar 2014
- Primary completion30 Nov 2016
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bobby Shayegan, St. Joseph's Healthcare Hamilton
- Investigators
- Bobby Shayegan, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605171
- Sponsor's protocol ID
- BFCRS-RP-U-01a
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Posterior Urethrovesical Reconstruction on Early Return to Urinary Continence Following Robot-assisted Radical Prostatectomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05605171
- Acronym / sponsor ID
- BFCRS-RP-U-01a
- Conditions
- Prostate Cancer
- Keywords
- Localized prostate cancer, Robot-assisted laparoscopic radical prostatectomy, Vesicourethral anastomosis, Posterior vesicourethral anastomosis reconstruction, Rocco stitch, Urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 4 Nov 2022 (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.
Urinary incontinence post radical prostatectomy is a well-recognized complication regardless of approach, with a potential negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in the literature, few patients are continent in the early postoperative period. It has been suggested that posterior reconstruction of the Denonvilliers' musculofascial plate, also known as the Rocco stitch, may improve early return to urinary continence, though clinical equipoise remains.
Detailed description
Each modality of prostate cancer treatment has the propensity to lead to negative outcomes on quality of life to varying degrees. It is our responsibility to incorporate into our practices the most beneficial treatment regimens that render patients' cancer-free while minimizing potential treatment-related adverse outcomes, including incontinence and erectile dysfunction. Urinary incontinence and erectile dysfunction are the two most well described complications of radical prostatectomy with observed rates of 8.4% and 59.9%, respectively. Delayed recovery of urinary continence following radical prostatectomy (RP) is a well-known entity. Numerous contributing factors have been identified for post-prostatectomy incontinence (PPI), including both patient (age, body mass index, membranous urethral length, prostate volume, pre-existing lower urinary tract symptoms, and oncologic factors) and surgeon characteristics (experience, technique).
In a systematic review a meta-analysis using a no pad or a single safety pad definition, Ficcara and colleagues showed that the 12-month urinary incontinence rates can range from 8% to 11%. As such, several reconstructive options have been incorporated into the contemporary RP to attempt to improve these outcomes. The anatomy of urethral-sphincteric vesico-prostatic complex is well-described, leading to attempts to perform reconstruction of the Denonvilliers' musculofascial plate during the urethrovesical anastomosis (UVA) at the time of RP. Performing a posterior reconstruction (PR) of the rhabdosphincter was first reported by Rocco et al. in 2006 during open retropubic RP, showing a 3, 30, and 90-day improvement in urinary continence post catheter removal.
Posterior reconstruction urethrovesical anastomosis (PR-UVA) has been hypothesized to improve the integrity of the rhabdosphincter and potentially increase the functional urethral length. However, a recent systematic review evaluating the efficacy of PR-UVA showed no improvement in urinary continence at 1 week and 3, 6, and 12 months. Conflicting studies within the literature render an environment of clinical equipoise in this specific patient-related outcome. Our study objective was to address the true clinical benefit of the PR-UVA in a large prospective randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior reconstruction urethrovesical anastomosis. | Experimental | Procedure: Posterior reconstruction urethrovesical anastomosis.The intervention comprised of a 2-stitch approximation of the free edge of the Denonvilliers' fascia and posterior bladder wall cranially, to the posterior aspect of the rhabdosphincter and the posterior median raphe caudally, respectively, following prostate extraction. The aim of this approach is to ultimately restore the length of the urethrosphincteric complex, prevent its caudal retraction, and avoid undue tension on the subsequent vesicourethral anastomosis, and provide a posterior support to the urethral sphincter complex to facilitate its effective contraction. |
| Conventional urethrovesical anastomosis. | Active comparator | Procedure: Conventional vesicourethral anastomosis.The conventional is fashioned with a continuous running technique that uses two sutures. The first suture is passed in a clockwise hemicircumferential manner, starting from outside in on the bladder neck at the 5 o'clock position and inside out on the urethra up toward the 12 o'clock position. The second suture is similarly run in a counter- clockwise hemicircumferential direction. The running sutures are snug down after each apposition to ensure there is no slack, and finally tied together with several knots at the 12 o'clock position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient over age 18 (with the ability to give informed consent) with localized prostate cancer (cT1-2, N0, M0).
Key exclusion criteria (3 listed)
- History of previous prostatic and/or urethral surgery
- A known history of a disease or comorbidity that could affect continence, such as insulin-dependent diabetes or urethral stenosis
- Presence of a urinary catheter preventing preoperative evaluation of continence.
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 |
|---|---|---|
| Posterior reconstruction urethrovesical anastomosis.Rocco stitch. | Procedure or surgery | Posterior reconstruction urethrovesical anastomosis. |
| Conventional vesicourethral anastomosis.Standard of care. | Procedure or surgery | Conventional urethrovesical anastomosis. |
Primary outcome
Return to urinary incontinence
Time frame: 12 months post procedure
The validated EPIC-26 (The Expanded Prostate Cancer Index Composite) Short Form (© The University of Michigan).
1 secondary outcome
Need for incontinence improving procedure
Time frame: 5 years post surgery
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 4 Nov 2022.
- 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.
Bobby Shayegan, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Posterior reconstruction urethrovesical anastomosis. and Conventional vesicourethral anastomosis. in people with Prostate Cancer, run by St. Joseph's Healthcare Hamilton.
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 1 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 4 Nov 2022. 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?
Return to urinary incontinence (time frame: 12 months post procedure). 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 4 Nov 2022.