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/21334025Actively Recruiting
Led by Suzhou Municipal Hospital · Updated on 2024-12-31
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy
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Total: 1 location
1
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
Actively Recruiting
T
Tengyue Zeng, doctor
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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