Urinary IncontinencePhase 3NCT02352103
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
A Phase 3 study testing Retzius sparing radical prostatectomy, Vattikuti Urology Institute radical prostatectomy and da Vinci Surgical System in people with Urinary Incontinence, run by Henry Ford Health System at 2 sites in United States.
Trial summary
To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Retzius sparing radical prostatectomy, Vattikuti Urology Institute radical prostatectomy and da Vinci Surgical System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to May 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
- Be able to read and speak English and be able to provide written informed consent
Who cannot join
- patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
- evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
- patients participating in a competing study
- patients with pre-operative urinary incontinence.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
About this study
Official title: The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.
Read the detailed description
Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.
- Conditions
- Urinary Incontinence
- Being tested
- Retzius sparing radical prostatectomy, Vattikuti Urology Institute radical prostatectomy, da Vinci Surgical System
- Keywords
- prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy
- Medical subject headings
- Urinary Incontinence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retzius sparing radical prostatectomyProcedure or surgery
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
Vattikuti Urology Institute radical prostatectomyProcedure or surgery
Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
da Vinci Surgical SystemDevice
The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System Receives: Procedure: Vattikuti Urology Institute radical prostatectomy; Device: da Vinci Surgical System |
| Treatment arm | Experimental | Retzius sparing radical prostatectomy da Vinci Surgical System Receives: Procedure: Retzius sparing radical prostatectomy; Device: da Vinci Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Continence Recovery
24-hour pad weights
Measured: One week after the removal of the suprapubic urinary catheter
Secondary outcomes (5)
Number of Participants With Urinary Continence Recovery
0 pad per day
Measured: within 3 months from the intervention
Number of Participants With Peri and Postoperative Complications
Clavien-Dindo complications
Measured: 1-year median follow up
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED
Measured: 1-year median follow up
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)
Measured: 1-year median follow up
Post-operative Urinary Function and Urinary Function-related Quality of Life
International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Measured: Within 3 months from the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mani Menon, Henry Ford Health System
- Investigators
- Mani Menon, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352103
- Sponsor's protocol ID
- 9220
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2015
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6.
PubMed 28483330Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7.
PubMed 29225060
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02352103
- Acronym / sponsor ID
- 9220
- Conditions
- Urinary Incontinence
- Keywords
- prostate cancer, Urinary continence, robotic assisted radical prostatectomy, Vattikuti Urology Institute (VIP) radical prostatectomy, Retzius sparing radical prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Posted 18 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.
Detailed description
Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Procedure: Vattikuti Urology Institute radical prostatectomy, Device: da Vinci Surgical SystemVattikuti Urology Institute radical prostatectomy da Vinci Surgical System |
| Treatment arm | Experimental | Procedure: Retzius sparing radical prostatectomy, Device: da Vinci Surgical SystemRetzius sparing radical prostatectomy da Vinci Surgical System |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
- Be able to read and speak English and be able to provide written informed consent
Key exclusion criteria (4 listed)
- patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
- evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
- patients participating in a competing study
- patients with pre-operative urinary incontinence.
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 |
|---|---|---|
| Retzius sparing radical prostatectomyRobotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique | Procedure or surgery | Treatment arm |
| Vattikuti Urology Institute radical prostatectomyRobotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique | Procedure or surgery | Control arm |
| da Vinci Surgical SystemThe da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery. | Device | Control arm, Treatment arm |
Primary outcome
Urinary Continence Recovery
Time frame: One week after the removal of the suprapubic urinary catheter
24-hour pad weights
5 secondary outcomes
Number of Participants With Urinary Continence Recovery
Time frame: within 3 months from the intervention
Number of Participants With Peri and Postoperative Complications
Time frame: 1-year median follow up
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
Time frame: 1-year median follow up
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
Time frame: 1-year median follow up
Post-operative Urinary Function and Urinary Function-related Quality of Life
Time frame: Within 3 months from the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28483330Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6.
- Results publication: PubMed 29225060Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7.
- A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical ProstatectomyLink provided by the sponsor.
- Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard ApproachesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mani Menon, MD principal investigator
Henry Ford Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retzius sparing radical prostatectomy, Vattikuti Urology Institute radical prostatectomy and da Vinci Surgical System in people with Urinary Incontinence, run by Henry Ford Health System at 2 sites in United States.
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 2 inclusion and 4 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Continence Recovery (time frame: One week after the removal of the suprapubic urinary catheter). 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 NCT02352103, which also lists 2 linked publications.
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 25 Feb 2022.