NCT06850116

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

February 24, 2025

Last Update Submit

April 1, 2025

Conditions

Prostate Cancer (Post Prostatectomy)Urinary ContinenceRetzius-sparing Robot-assisted Radical Prostatectomy

Keywords

Retzius-sparing robot-assisted radical prostatectomyProstate Cancerurinary continence

Outcome Measures

Primary Outcomes (1)

  • rate of continence

    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

Study Arms (1)

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

Interventions

Retzius-sparing robot-assisted radical prostatectomyPROCEDURE

Retzius-sparing robot-assisted radical prostatectomy

The Retzius-sparing robot-assisted radical prostatectomy group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer patients underwent RS-RARP.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 27, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

CN(1)