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
N/A
Total Duration
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
A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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