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The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery

NCT06543420 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-08-09

No results posted yet for this study

Summary

This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.

Conditions

Interventions

PROCEDURE

lateral reconstruction

In lateral reconstruction group, lateral reconstruction is performed by suturing the levator ani muscle to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.

PROCEDURE

posterior reconstruction

In posterior group, prior to completion of the operation, the posterior fibrous tissues of the sphincter are joined to the residual Denonvilliers fascia on the posterior bladder wall 1-2 cm cephalad and dorsally to the new bladder neck.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Kan Gong · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2025-07-21
Completion
2026-07-21

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543420 on ClinicalTrials.gov