Impact of Anterior Urethral Suspension Combined With Pelvic Fascia Reconstruction During Robot-Assisted Radical Prostatectomy on Early Postoperative Urinary Continence Recovery: A Single-Center, Prospective, Single-Arm Clinical Study

NCT07725653 | Completed DMC

• 1 other identifier: NCC6160
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. The primary endpoint is the 3-month postoperative urinary continence recovery rate. Secondary endpoints include positive surgical margin rate, intraoperative blood loss, operative duration, postoperative complications, biochemical recurrence and other indicators. Standardized surgical procedures, standardized follow-up and multi-dimensional statistical analyses will be performed to clarify the functional benefits and oncological safety of this modified technique, so as to optimize surgical strategies for locally advanced prostate cancer.

Conditions

Prostate Cancer

Keywords

Robot-assisted radical prostatectomy, urinary continence, pelvic fascia reconstruction, anterior urethral suspension

Outcome Measures

Primary Outcomes (2)

• Early urinanry continence recovery rate

  Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.

  3 consecutive months postoperatively

• Urinary continence recovery rate

  Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.

  3 consecutive months postoperatively

Study Arms (1)

Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction

EXPERIMENTAL

This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.

Procedure: Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction

Interventions

Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction PROCEDURE

This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.

Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Only male patients with prostate cancer are eligible for enrollment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Pathologically confirmed prostate cancer;
• \. Scheduled to undergo modified robot-assisted radical prostatectomy;
• \. Able to complete regular postoperative follow-up and functional assessment;
• \. Voluntarily sign written informed consent.

You may not qualify if:

• \. Previous history of pelvic radiotherapy or prostate surgery;
• \. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery;
• \. Neurogenic bladder or severe preoperative urinary incontinence;
• \. Cognitive impairment making follow-up assessment impossible.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a single-group prospective cohort study. All enrolled patients with localized or locally advanced prostate cancer receive a standardized surgical procedure: modified robot-assisted radical prostatectomy with anterior urethral suspension plus pelvic fascia reconstruction. No control group is established. Telephone follow-ups will be conducted at 1, 2, and 3 months postoperatively to evaluate urinary continence status and monitor biochemical recurrence.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: December 12, 2025
• Primary Completion: July 10, 2026
• Study Completion: July 11, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CN (1)