RecruitingNot ApplicableNCT06543420

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

The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial


Sponsor

Peking University First Hospital

Enrollment

192 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a surgical technique that rebuilds a specific pelvic muscle (the levator ani) during robotic prostate removal surgery helps men regain urinary control faster after the operation. **You may be eligible if...** - You have been diagnosed with prostate cancer at a clinical stage of cT2 to cT3a, with no lymph node or distant spread (N0M0) - You meet the standard criteria to have robotic-assisted radical prostatectomy **You may NOT be eligible if...** - You have a history of urinary incontinence or a narrowed urethra before surgery - You have had previous prostate surgery - You have a medical reason that prevents you from having robotic surgery - You or your family decline to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURElateral 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.

PROCEDUREposterior 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.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06543420


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