Clinical trial · Interventional
A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy
A New Vesicocervical Urethral Reconstruction Technique Improves Urinary Continence in Patients After Laparoscopic Radical Prostatectomy: a Single-center Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Laparoscopic radical prostatectomy (LRP) is the main treatment method for early prostate cancer, and postoperative urinary incontinence is one of the main complications after LRP. Urologists have applied various new operations in clinical practice to improve the urinary incontinence of patients after LRP surgery, but urinary incontinence is still the main problem affecting the quality of life of patients after surgery. In recent years, we have found that the new bladder neck urethral reconstruction method adopted by our department in LRP surgery can effectively improve the postoperative urinary incontinence of patients. In this study, a randomized controlled trial was intended to verify that the new bladder and neck urethral reconstruction technique could effectively improve early urinary control in patients after radical laparoscopic prostatectomy, and the patients were randomly divided into four groups by factorial design: posterior reconstruction group, posterior reconstruction +anterior suspension group, Sham group, and anterior suspension group to further verify the influencing factors of improved urinary control. The aim is to prove that the new operation can effectively reduce the urinary incontinence rate of patients after LRP, and analyze the mechanism of the new operation to improve the urinary incontinence of patients after LRP, and provide a new idea for the reconstruction of bladder neck and urethra during laparoscopic radical prostatectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anterior Bladder Wall Reconstruction | — | UNRESOLVED | — |
| Anterior Bladder Wall Suspension | — | UNRESOLVED | — |
| Posterior Bladder Wall Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anterior suspension | Procedure | — | UNRESOLVED |
| Posterior Reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- posterior reconstruction group
- description
- In the posterior wall reconstruction group, laparoscopic radical prostatectomy was performed using an extraperitoneal approach:(1)The extraperitoneal space was established, and Trocar was placed.(2)The Retzius space was separated, the pelvic fascia on both sides of the prostate was incised, the bilateral puboprostatic ligaments were severed, and the dorsal vein complex (DVC) was sutured with 2-0 barb wire.(3)The bladder neck was severed.(4)The prostate and seminal vesicles were separated, the Denonvilliers fascia was opened, and the prostate gland was bluntly and sharply separated from the apex. The lateral prostatic ligaments were severed on both sides.(5)The prostate tip and urethra were severed.(6)Bladder neck reconstruction and bladder neck urethral anastomosis were performed: The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.
- interventionNames
- Procedure: Posterior Reconstruction
- type
- EXPERIMENTAL
- label
- posterior reconstruction + anterior suspension group
- description
- In the posterior reconstruction + anterior suspension group, laparoscopic radical prostatectomy with an extraperitoneal approach (steps 1 to 5) was performed similarly to the posterior wall reconstruction group.(6) The bladder neck was reconstructed using the "inverted tennis racket" method to reduce the bladder neck, extend the back wall of the bladder, and anastomose the vesical-urethra.(7)the anterior wall of the bladder was continuously sutured and fixed onto the muscular membrane of the lower margin of the symphysis pubis using a barb suture.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: (1) Preoperative needle biopsy confirmed prostate cancer; (2) The clinical stage is T1 and T2 Exclusion Criteria: (1) Diseases that significantly increase the risk of surgery or anesthesia, such as severe cardiovascular diseases, respiratory diseases, and coagulation disorders. (2) Patients with extensive bone metastasis or metastases to other organs (3) patients with a history of urinary incontinence and transurethral resection of the prostate. (4) Tumor invasion of bladder neck.
References
Publications (20)
- BACKGROUNDSutherland DE, Linder B, Guzman AM, Hong M, Frazier HA 2nd, Engel JD, Bianco FJ Jr. Posterior rhabdosphincter reconstruction during robotic assisted radical prostatectomy: results from a phase II randomized clinical trial. J Urol. 2011 Apr;185(4):1262-7. doi: 10.1016/j.juro.2010.11.085. Epub 2011 Feb 22. PMID 21334025
- BACKGROUNDSoda T, Otsuka H, Koike S, Okada T. Baseline factors and surgical procedures affecting changes in lower urinary tract symptoms after robot-assisted radical prostatectomy: the impact of nerve-sparing. Int Urol Nephrol. 2024 Mar;56(3):989-997. doi: 10.1007/s11255-023-03859-9. Epub 2023 Oct 31. PMID 37907707
- BACKGROUNDZhao X, Li K, Zhuang R, Liu H, He W, Dong W, Huang H, Huang J, Lin T. Comparison in Efficacy of Periurethral Reconstruction Leading to Urinary Continence Improvement After Robot-assisted Radical Prostatectomy. Ann Surg Oncol. 2024 Dec;31(13):8978-8985. doi: 10.1245/s10434-024-16225-5. Epub 2024 Sep 17. PMID 39287903
- BACKGROUNDOrtner G, Honis HR, Bohm J, Konschake M, Tokas T, Nagele U. Improved early continence following laparoscopic radical prostatectomy: the urethral hammock technique. World J Urol. 2024 Mar 16;42(1):168. doi: 10.1007/s00345-024-04857-x. PMID 38492077
- BACKGROUNDSakai I, Harada K, Hara I, Eto H, Miyake H. Intussusception of the bladder neck does not promote early restoration to urinary continence after non-nerve-sparing radical retropubic prostatectomy. Int J Urol. 2005 Mar;12(3):275-9. doi: 10.1111/j.1442-2042.2005.01070.x. PMID 15828955
- BACKGROUNDRocco F, Carmignani L, Acquati P, Gadda F, Dell'Orto P, Rocco B, Bozzini G, Gazzano G, Morabito A. Restoration of posterior aspect of rhabdosphincter shortens continence time after radical retropubic prostatectomy. J Urol. 2006 Jun;175(6):2201-6. doi: 10.1016/S0022-5347(06)00262-X. PMID 16697841
- Catarin MV, Manzano GM, Nobrega JA, Almeida FG, Srougi M, Bruschini H. The role of membranous urethral afferent autonomic innervation in the continence mechanism after nerve sparing radical prostatectomy: a clinical and prospective study. J Urol. 2008 Dec;180(6):2527-31. doi: 10.1016/j.juro.2008.08.020. Epub 2008 Oct 19.