Actively Recruiting

Phase Not Applicable
Age: 0 - 79Years
MALE
ID06754488

A New Vesicocervical Urethral Reconstruction Technique Improves Urinary Continence in Patients After Laparoscopic Radical Prostatectomy: a Single-center Randomized Controlled Trial

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

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Prostate cancer is a common malignant tumor in men, with laparoscopic radical prostatectomy (LRP) being a primary treatment for early stages. Postoperative urinary incontinence remains a major complication affecting quality of life. This trial evaluates a new bladder neck and urethral reconstruction technique during LRP to improve early urinary control, comparing it with conventional methods through a randomized controlled design involving four patient groups. The study includes four groups receiving different surgical procedures: posterior wall reconstruction using an "inverted tennis racket" method, posterior reconstruction combined with anterior suspension, a sham surgery group, and an anterior suspension group alone. All groups undergo LRP via an extraperitoneal approach. The new technique involves reconstructing the bladder neck to narrow its opening and lengthen the posterior bladder wall, with some groups also receiving suturing of the anterior bladder wall to support the urethra. Participants are followed after surgery to assess urinary control immediately after catheter removal and at 1, 3, 6, and 12 months post-operation. Assessments use the International Consultation on Incontinence Questionnaire-Short Form, daily urine pad usage, and 24-hour pad weight. The primary outcome is the rate of continence at these time points. Safety and quality of life effects are also monitored throughout the study, which lasts at least one year post-surgery.

CONDITIONS

Brief 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 stages T1 or T2
  • Male patients
  • Age younger than 80 years old
Not Eligible

You will not qualify if you...

  • Severe cardiovascular, respiratory, or clotting diseases increasing surgery risk
  • Extensive bone or other organ metastases
  • History of urinary incontinence or prior 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo laparoscopic radical prostatectomy with different bladder neck and urethral reconstruction techniques depending on their assigned group.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are monitored for urinary continence and recovery after surgery at multiple time points.

Visits immediately after catheter removal and at 1 month, 3 months, 6 months, and 12 months post-surgery

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