Analysis of Immediate Urinary Continence Predictors After RS-RARP

April 1, 2025 updated by: First Affiliated Hospital of Fujian Medical University

Analysis of Immediate Urinary Continence Predictors After Retzius-sparing Robot-assisted Radical Prostatectomy: A Single-center Retrospective Clinical Study

This study is a retrospective, single-center clinical trial. It aims to retrospectively analyze the immediate postoperative urinary continence recovery in prostate cancer patients who underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' center. Based on the general conditions of patients, relevant perioperative clinical indicators, and parameters related to the sphincter and prostate gland measured by MRI, it explores the influencing factors of immediate urinary continence recovery after Retzius-sparing robot-assisted radical prostatectomy in prostate cancer patients and constructs a relevant prediction model, thereby providing clinical guidance value for predicting immediate postoperative urinary continence recovery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

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

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • first hospital affiliated of Fujian medical university

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prostate cancer patients underwent RS-RARP.

Description

Inclusion Criteria:

  • Prostate cancer diagnosed by prostate biopsy and underwent Retzius-sparing robot-assisted radical prostatectomy in the investigators' hospital.
  • Received plain and contrast-enhanced pelvic or prostate MRI examinations before surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1.
  • Complete clinicopathological data.
  • In good general condition, without infections, autoimmune diseases, hematological diseases or other malignant tumors.
  • Complete postoperative follow-up data, with a postoperative follow-up time of no less than 6 months.

Exclusion Criteria:

  • The patient has surgical contraindications.
  • The patient has contraindications for MRI examination.
  • Preoperative presence of congenital urinary system malformations, urinary incontinence or severe lower urinary tract symptoms, and with a history of urinary catheter or previous transurethral resection of the prostate (TURP) surgery.
  • Having received neoadjuvant treatments that may affect the results of this study, such as radiotherapy or hormonal therapy.
  • The patient has other concurrent malignant tumors.
  • The patient has delayed extubation (> 14 days).
  • The patient's clinical, imaging and pathological data are incomplete or the patient is lost to follow-up.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The Retzius-sparing robot-assisted radical prostatectomy group
In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the Retzius-sparing robot-assisted radical prostatectomy group group who undergo the posterior approach extrafascial technique of RS-RARP.
Procedure: Retzius-sparing robot-assisted radical prostatectomy
Retzius-sparing robot-assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of continence
Time Frame: rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
Time Frame: 1 week after postoperative removal of the urinary catheter
rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Fujian Medical University

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)

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH OfFMUI2025]002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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