Radical ProstatectomyContinenceNCT07899268
Continence Post Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy
A study testing Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) and Standard Robot-Assisted Radical Prostatectomy (S-RARP) in people with Radical Prostatectomy and Robotic Radical Prostatectomy, run by Armed Forces College of Medicine, Cairo, Egypt at 1 site in Egypt.
Trial summary
To compare the short term (three month) continence rates using versius robotic system between the Retzius-sparing and the standard RARP within three month from removal of catheter. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Radical Prostatectomy, Robotic Radical Prostatectomy, Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction
- What is being tested?
- Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) and Standard Robot-Assisted Radical Prostatectomy (S-RARP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2025to 30 Jun 2026
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical Stage: Clinical T1-2 N0 M0 prostate cancer.
- Prostate Size: Less than 100 gm.
Who cannot join
- High-risk prostate cancer.
- Patients refusing Surgery.
- Patients unfit for surgery.
- History of previous TURP.
- Salvage Prostatectomy.
- Post Biopsy Febrile Prostatitis.
- Patients with retention and voiding dysfunction.
- Body mass index > 40
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Armed Forces College of Medicine , Cairo, Egypt.
Cairo, Cairo Governorate
About this study
Official title: Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy: A Prospective Randomized Comparison on Immediate Continence Rates Using Versius Robotic System
To compare the short term (three month) continence rates using versius robotic system between the Retzius-sparing and the standard RARP within three month from removal of catheter.
Read the detailed description
Prostate cancer has the highest incidence rate and second highest mortality rate among cancers in men, accounting for a significant portion of new cancer diagnoses and cancer-related deaths.
Robot-Assisted Radical Prostatectomy (RARP) has become a standard treatment for localized prostate cancer, offering advantages such as reduced blood loss, shorter hospital stays, and quicker recovery compared to traditional open surgery. The use of advanced robotic platforms, including the Versius robotic system, has significantly improved precision in prostatectomy procedures.
Urinary continence remains one of the most important functional outcomes for patients undergoing radical prostatectomy. Despite advances in surgical techniques, many patients experience transient postoperative incontinence, which significantly impacts quality of life. The preservation of the puboprostatic ligaments and anterior bladder structures during surgery has been identified as a key factor in reducing the risk of incontinence.
Radical prostatectomy can be performed open, laparoscopically, or robot-assisted. Minimally invasive radical prostatectomy has become more common, utilizing two primary approaches for RARP: the standard/anterior approach and the Retzius-sparing/posterior approach (RS-RARP). In RS-RARP, the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space and leading to major improvements in functional outcomes, particularly immediate continence recovery.
Urinary incontinence remains one of the main risks following radical prostatectomy regardless of the surgical technique used. Incontinence rates can vary depending on the assessment questionnaires utilized, such as the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). Total urinary continence after catheter removal increases progressively over time.
Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) is reported to be associated with better immediate continence compared to the standard anterior approach, with no differences observed in longer-term functional recovery, quality of life, or other key outcomes. Furthermore, potency and serious complication rates appear comparable, showing no significant differences in the preservation of erectile function or overall postoperative complication rates between the two techniques.
- Conditions
- Radical Prostatectomy, Robotic Radical Prostatectomy, Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction
- Being tested
- Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP), Standard Robot-Assisted Radical Prostatectomy (S-RARP)
- Keywords
- Retzius-sparing and the standard RARP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)Procedure or surgery
Also called Retzius-sparing (posterior) robot-assisted radical prostatectomy
Patients undergo Retzius-sparing (posterior) robot-assisted radical prostatectomy using the Versius robotic system, where the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space.
Standard Robot-Assisted Radical Prostatectomy (S-RARP)Procedure or surgery
Also called standard (anterior) robot-assisted radical prostatectomy
Patients undergo standard (anterior) robot-assisted radical prostatectomy using the Versius robotic system through Retzius space
| Study group | Role | What they receive |
|---|---|---|
| Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) | Experimental | Patients undergo Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) using the Versius robotic system. Receives: Procedure: Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) |
| Standard Robot-Assisted Radical Prostatectomy (S-RARP) | Active comparator | Patients undergo standard (anterior) robot-assisted radical prostatectomy (S-RARP) using the Versius robotic system. Receives: Procedure: Standard Robot-Assisted Radical Prostatectomy (S-RARP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Continence Rate
The proportion of patients who achieve urinary continence (defined as the need for 0-1 pad per day) within a specified postoperative period e.g., 7 days or 30 days or 3 months.
Measured: Within three month from removal of the catheter (the short-term/first month and three months postoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start6 Feb 2025
- Primary completion1 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radical ProstatectomyStudies 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
- Model description
- "Patients will be randomly allocated into two parallel groups-the Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) group and the standard robot-assisted radical prostatectomy (S-RARP) group-using a computer program to ensure equal distribution."
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces College of Medicine, Cairo, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hassan Ahmed Aly, Armed Forces College of Medicine, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899268
- Sponsor's protocol ID
- Robotic Radical Prostatectomy
- Acronym
- Continence
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Skornick-Rapaport A, Maslovitz S, Kupferminc M, Lessing JB, Many A. Proposed management for reduced fetal movements: five years' experience in one medical center. J Matern Fetal Neonatal Med. 2011 Apr;24(4):610-3. doi: 10.3109/14767058.2010.511338. Epub 2010 Sep 9.
PubMed 20828236White AA 3rd. Resident selection: are we putting the cart before the horse? Clin Orthop Relat Res. 2002 Jun;(399):255-9. doi: 10.1097/00003086-200206000-00032.
PubMed 12011718
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy: A Prospective Randomized Comparison on Immediate Continence Rates Using Versius Robotic System
- ClinicalTrials.gov ID
- NCT07899268
- Acronym / sponsor ID
- Continence / Robotic Radical Prostatectomy
- Conditions
- Radical Prostatectomy, Robotic Radical Prostatectomy, Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction
- Keywords
- Retzius-sparing and the standard RARP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Armed Forces College of Medicine, Cairo, EgyptUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Oct 2026 (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.
To compare the short term (three month) continence rates using versius robotic system between the Retzius-sparing and the standard RARP within three month from removal of catheter.
Detailed description
Prostate cancer has the highest incidence rate and second highest mortality rate among cancers in men, accounting for a significant portion of new cancer diagnoses and cancer-related deaths.
Robot-Assisted Radical Prostatectomy (RARP) has become a standard treatment for localized prostate cancer, offering advantages such as reduced blood loss, shorter hospital stays, and quicker recovery compared to traditional open surgery. The use of advanced robotic platforms, including the Versius robotic system, has significantly improved precision in prostatectomy procedures.
Urinary continence remains one of the most important functional outcomes for patients undergoing radical prostatectomy. Despite advances in surgical techniques, many patients experience transient postoperative incontinence, which significantly impacts quality of life. The preservation of the puboprostatic ligaments and anterior bladder structures during surgery has been identified as a key factor in reducing the risk of incontinence.
Radical prostatectomy can be performed open, laparoscopically, or robot-assisted. Minimally invasive radical prostatectomy has become more common, utilizing two primary approaches for RARP: the standard/anterior approach and the Retzius-sparing/posterior approach (RS-RARP). In RS-RARP, the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space and leading to major improvements in functional outcomes, particularly immediate continence recovery.
Urinary incontinence remains one of the main risks following radical prostatectomy regardless of the surgical technique used. Incontinence rates can vary depending on the assessment questionnaires utilized, such as the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). Total urinary continence after catheter removal increases progressively over time.
Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) is reported to be associated with better immediate continence compared to the standard anterior approach, with no differences observed in longer-term functional recovery, quality of life, or other key outcomes. Furthermore, potency and serious complication rates appear comparable, showing no significant differences in the preservation of erectile function or overall postoperative complication rates between the two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- "Patients will be randomly allocated into two parallel groups-the Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) group and the standard robot-assisted radical prostatectomy (S-RARP) group-using a computer program to ensure equal distribution."
| Arm | Type | Receives |
|---|---|---|
| Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) | Experimental | Procedure: Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)Patients undergo Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) using the Versius robotic system. |
| Standard Robot-Assisted Radical Prostatectomy (S-RARP) | Active comparator | Procedure: Standard Robot-Assisted Radical Prostatectomy (S-RARP)Patients undergo standard (anterior) robot-assisted radical prostatectomy (S-RARP) using the Versius robotic system. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Stage: Clinical T1-2 N0 M0 prostate cancer.
- Prostate Size: Less than 100 gm.
Key exclusion criteria (8 listed)
- High-risk prostate cancer.
- Patients refusing Surgery.
- Patients unfit for surgery.
- History of previous TURP.
- Salvage Prostatectomy.
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 |
|---|---|---|
| Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)Also: Retzius-sparing (posterior) robot-assisted radical prostatectomyPatients undergo Retzius-sparing (posterior) robot-assisted radical prostatectomy using the Versius robotic system, where the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space. | Procedure or surgery | Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) |
| Standard Robot-Assisted Radical Prostatectomy (S-RARP)Also: standard (anterior) robot-assisted radical prostatectomyPatients undergo standard (anterior) robot-assisted radical prostatectomy using the Versius robotic system through Retzius space | Procedure or surgery | Standard Robot-Assisted Radical Prostatectomy (S-RARP) |
Primary outcome
Immediate Continence Rate
Time frame: Within three month from removal of the catheter (the short-term/first month and three months postoperative period).
The proportion of patients who achieve urinary continence (defined as the need for 0-1 pad per day) within a specified postoperative period e.g., 7 days or 30 days or 3 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 27 Oct 2026.
- Background: PubMed 20828236Skornick-Rapaport A, Maslovitz S, Kupferminc M, Lessing JB, Many A. Proposed management for reduced fetal movements: five years' experience in one medical center. J Matern Fetal Neonatal Med. 2011 Apr;24(4):610-3. doi: 10.3109/14767058.2010.511338. Epub 2010 Sep 9.
- Background: PubMed 12011718White AA 3rd. Resident selection: are we putting the cart before the horse? Clin Orthop Relat Res. 2002 Jun;(399):255-9. doi: 10.1097/00003086-200206000-00032.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) and Standard Robot-Assisted Radical Prostatectomy (S-RARP) in people with Radical Prostatectomy and Robotic Radical Prostatectomy, run by Armed Forces College of Medicine, Cairo, Egypt at 1 site in Egypt.
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 8 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 27 Oct 2026. 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 Egypt. 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?
Immediate Continence Rate (time frame: Within three month from removal of the catheter (the short-term/first month and three months postoperative period).). 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 NCT07899268, 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 27 Oct 2026.