Continence Post Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy (Continence)

November 6, 2026 updated by: Mohammed Hassan Ahmed Aly, Armed Forces College of Medicine, Cairo, Egypt

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Urology Department, Kasr Al-Ainy school of medicine,Cairo University
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Armed Forces College of Medicine , Cairo, Egypt.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical Stage: Clinical T1-3 N0 M0 prostate cancer.
  • Prostate Size: Less than 100 gm.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)

Patients undergo Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) using the Versius robotic system.
Procedure: Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)

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.

Other Names:
  • Retzius-sparing (posterior) robot-assisted radical prostatectomy
Active Comparator: Standard Robot-Assisted Radical Prostatectomy (S-RARP)

Patients undergo standard (anterior) robot-assisted radical prostatectomy (S-RARP) using the Versius robotic system.
Procedure: Standard Robot-Assisted Radical Prostatectomy (S-RARP)

Patients undergo standard (anterior) robot-assisted radical prostatectomy using the Versius robotic system through Retzius space

Other Names:
  • standard (anterior) robot-assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary Continence (0-1 pads/day)
Time Frame: 1 week after catheter removal

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.
1 week after catheter removal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continence at 1 and 3 months
Time Frame: 1 and 3 months after catheter removal

ICIQ-UI score at 1 month and 3 months after catheter removal
1 and 3 months after catheter removal
Assessing positive surgical margins
Time Frame: 1 week and 3 months

Assessment of PSMs postoperatively to assess the oncological outcomes and assessment of PSA level at 3 months
1 week and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Armed Forces College of Medicine, Cairo, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Robotic Radical Prostatectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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