Actively Recruiting

Phase Not Applicable
Age: 0 - 79Years
MALE
ID06754488

A New Bladder Neck and Urethral Reconstruction Technique to Improve Urinary Continence After Laparoscopic Radical Prostatectomy A Single-center Randomized Controlled Trial Evaluating Posterior Reconstruction and Anterior Suspension Methods

Led by Suzhou Municipal Hospital · Updated on 2024-12-31

120

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Prostate cancer is a common cancer in men, and laparoscopic radical prostatectomy (LRP) is a primary surgical treatment for early-stage cases. However, urinary incontinence after LRP remains a significant complication that affects patients' quality of life. This research aims to evaluate a new bladder neck and urethral reconstruction technique to improve early urinary control after LRP. The study is a randomized controlled trial with four groups to compare different surgical methods and their impact on urinary continence. The study involves four groups of patients undergoing LRP via an extraperitoneal approach: posterior reconstruction, posterior reconstruction combined with anterior suspension, sham, and anterior suspension groups. The new technique uses an "inverted tennis racket" method to reconstruct the bladder neck by narrowing its opening and lengthening the posterior bladder wall, followed by suturing the bladder and urethra. In some groups, the anterior bladder wall is also sutured and fixed to support urinary control. Conventional bladder neck reconstruction methods are used in the control groups. Participants are monitored immediately after catheter removal and at 1, 3, 6, and 12 months after surgery to assess urinary continence. Evaluations include questionnaires about incontinence, daily urine pad usage, and 24-hour pad weight measurements. Researchers focus on the rate of urinary continence and recovery of bladder control over time to determine if the new surgical method reduces urinary incontinence and improves patient quality of life after LRP.

CONDITIONS

Official Title

A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy

Who Can Participate

Age: 0 - 79Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Preoperative needle biopsy confirmed prostate cancer
  • Clinical stage T1 or T2
Not Eligible

You will not qualify if you...

  • Diseases that significantly increase the risk of surgery or anesthesia, such as severe cardiovascular diseases, respiratory diseases, and coagulation disorders
  • Extensive bone metastasis or metastases to other organs
  • History of urinary incontinence or transurethral resection of the prostate
  • Tumor invasion of the bladder neck

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
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3
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Trial Site Locations

Total: 1 location

1

Suzhou Municipal Hospital

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

T

Tengyue Zeng, doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

Frequently Asked Questions

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Published Research Related To This Trial

Posterior rhabdosphincter reconstruction during robotic assisted radical prostatectomy: results from a phase II randomized clinical trial.

Douglas E Sutherland, Brian Linder, Anna M Guzman...

https://pubmed.ncbi.nlm.nih.gov/21334025

Baseline factors and surgical procedures affecting changes in lower urinary tract symptoms after robot-assisted radical prostatectomy: the impact of nerve-sparing.

Takeshi Soda, Hikari Otsuka, Shuhei Koike...

https://pubmed.ncbi.nlm.nih.gov/37907707

Comparison in Efficacy of Periurethral Reconstruction Leading to Urinary Continence Improvement After Robot-assisted Radical Prostatectomy.

Xutu Zhao, Kaiwen Li, Ruilin Zhuang...

https://pubmed.ncbi.nlm.nih.gov/39287903

Intussusception of the bladder neck does not promote early restoration to urinary continence after non-nerve-sparing radical retropubic prostatectomy.

Iori Sakai, Ken-Ichi Harada, Isao Hara...

https://pubmed.ncbi.nlm.nih.gov/15828955

The role of membranous urethral afferent autonomic innervation in the continence mechanism after nerve sparing radical prostatectomy: a clinical and prospective study.

Marcos Vinicius Guarnieri Catarin, Gilberto Mastrocola Manzano, João A M Nóbrega...

https://pubmed.ncbi.nlm.nih.gov/18930493

A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy.

Jochen Walz, Arthur L Burnett, Anthony J Costello...

https://pubmed.ncbi.nlm.nih.gov/19931974