ClinicalTrials.gg
CompletedNCT07899268ContinenceUpdated Nov 12, 2026

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

An interventional study of Procedure: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP) and Standard Robot-Assisted Radical Prostatectomy (S-RARP) in Radical Prostatectomy, Robotic Radical Prostatectomy and Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction, sponsored by Armed Forces College of Medicine, Cairo, Egypt. Completed at 2 sites in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Armed Forces College of Medicine, Cairo, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2025, registered Oct 2026).
Updated Nov 12, 2026Start date movedPrimary completion moved+5 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Sex
Male
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Armed Forces College of Medicine, Cairo, Egypt is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 12, 2026. See what changed

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients refusing Surgery.
  • Patients unfit for surgery.
  • History of previous TURP.
  • Salvage Prostatectomy.
  • Post Febrile Prostatitis.
  • Patients with retention and voiding dysfunction.
  • > 40
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • ProcedureProcedure: 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.

    Also known as: Retzius-sparing (posterior) robot-assisted radical prostatectomy

  • ProcedureStandard Robot-Assisted Radical Prostatectomy (S-RARP)

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

    Also known as: standard (anterior) robot-assisted radical prostatectomy

06

What researchers measure

Primary outcomes

  1. Urinary Continence (0-1 pads/day)

    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.

    Time frame: 1 week after catheter removal

Secondary outcomes

  1. Continence at 1 and 3 months

    ICIQ-UI score at 1 month and 3 months after catheter removal

    Time frame: 1 and 3 months after catheter removal

  2. Assessing positive surgical margins

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

    Time frame: 1 week and 3 months

07

Study locations

2 sites
  • Armed Forces College of Medicine , Cairo, Egypt.
    Cairo, Cairo Governorate, Egypt
  • Urology Department, Kasr Al-Ainy school of medicine,Cairo University
    Cairo, Egypt
08

References and documents

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 20828236 ↗
  • White 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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Dec 2025 to primary completion in Jul 2026, 6 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: start Feb 2025 → Dec 2025, primary completion Mar 2026 → Jul 2026 and completion Jun 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 27, 2026
StartActual
Dec 6, 2025was Feb 2025
Primary completionActual
Jul 1, 2026was Mar 2026
CompletionActual
Sep 30, 2026was Jun 2026
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Urology Department, Kasr Al-Ainy school of medicine,Cairo University · Cairo, Egypt
Nov 12, 2026
Start date
Feb 6, 2025→Dec 6, 2025
Nov 12, 2026
Primary completion
Mar 1, 2026→Jul 1, 2026
Nov 12, 2026
Study completion
Jun 30, 2026→Sep 30, 2026
Nov 12, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion removed
What changed in the criteria
Inclusion criteria
  • EditedClinical Stage: Clinical T1-23 N0 M0 prostate cancer.
Exclusion criteria
  • RemovedHigh-risk prostate cancer.
Nov 12, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Immediate Continence RateNow Urinary Continence (0-1 pads/day)Time frame: Within three month from removal of the catheter (the short-term/first month and three months postoperative period). → 1 week after catheter removal
Nov 12, 2026
Secondary outcomes
2 added
What changed in the outcomes
  • AddedContinence at 1 and 3 monthsTime frame: 1 and 3 months after catheter removal
  • AddedAssessing positive surgical marginsTime frame: 1 week and 3 months
Nov 12, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Nov 12, 2026
    1 site added
    Show site
    • Urology Department, Kasr Al-Ainy school of medicine,Cairo University · Cairo, Egypt
    Start date Feb 6, 2025→Dec 6, 2025
    Primary completion Mar 1, 2026→Jul 1, 2026
    Study completion Jun 30, 2026→Sep 30, 2026
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion removed
    What changed in the criteria
    Inclusion criteria
    • EditedClinical Stage: Clinical T1-23 N0 M0 prostate cancer.
    Exclusion criteria
    • RemovedHigh-risk prostate cancer.
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Immediate Continence RateNow Urinary Continence (0-1 pads/day)Time frame: Within three month from removal of the catheter (the short-term/first month and three months postoperative period). → 1 week after catheter removal
    Secondary outcomes 2 added
    What changed in the outcomes
    • AddedContinence at 1 and 3 monthsTime frame: 1 and 3 months after catheter removal
    • AddedAssessing positive surgical marginsTime frame: 1 week and 3 months
    + 1 other change: verification date
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07899268
Lead sponsor
Armed Forces College of Medicine, Cairo, Egypt
Responsible party
Mohammed Hassan Ahmed Aly (Specialist Urologist and Principal Investigator, Armed Forces College of Medicine, Cairo, Egypt) — Principal investigator
First posted
Oct 27, 2026
Start date
Dec 6, 2025
Primary completion
Jul 1, 2026
Completion
Sep 30, 2026
Last update
Nov 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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