Clinical trial · Interventional
An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction
Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
NCT04037800CI-TRIAL-00058575completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SFUR-RARP | Procedure | — | UNRESOLVED |
| Standard RARP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SFUR-RARP
- description
- Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.
- interventionNames
- Procedure: SFUR-RARP
- type
- ACTIVE_COMPARATOR
- label
- Standard RARP
- description
- Patients in which standard RARP is performed.
- interventionNames
- Procedure: Standard RARP
Primary outcomes (1)
- measure
- 1-month urinary continence recovery rates
- timeFrame
- 1 month after catheter removal
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ≥40, but ≤75 years old； * Histological confirmed prostate cancer； * Localized or locally advanced prostate cancer； * Presence of urinary continence prior to the procedure; * Informed consent signed; Exclusion Criteria: * Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI; * Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure; * Radiation therapy of the prostate or pelvis prior to the procedure; * Uncontrolled intercurrent illness that would limit compliance with study requirements; * Any condition that contraindicates a radical prostatectomy;
References
Publications (5)
- BACKGROUNDFicarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1. PMID 22749852
- BACKGROUNDDev HS, Sooriakumaran P, Srivastava A, Tewari AK. Optimizing radical prostatectomy for the early recovery of urinary continence. Nat Rev Urol. 2012 Jan 24;9(4):189-95. doi: 10.1038/nrurol.2012.2. PMID 22270136
- BACKGROUNDBessede T, Sooriakumaran P, Takenaka A, Tewari A. Neural supply of the male urethral sphincter: comprehensive anatomical review and implications for continence recovery after radical prostatectomy. World J Urol. 2017 Apr;35(4):549-565. doi: 10.1007/s00345-016-1901-8. Epub 2016 Aug 2. PMID 27484205
- BACKGROUNDPavlovich CP, Rocco B, Druskin SC, Davis JW. Urinary continence recovery after radical prostatectomy - anatomical/reconstructive and nerve-sparing techniques to improve outcomes. BJU Int. 2017 Aug;120(2):185-196. doi: 10.1111/bju.13852. Epub 2017 Apr 17. PMID 28319318
- BACKGROUNDBianchi L, Turri FM, Larcher A, De Groote R, De Bruyne P, De Coninck V, Goossens M, D'Hondt F, De Naeyer G, Schatteman P, Mottrie A. A Novel Approach for Apical Dissection During Robot-assisted Radical Prostatectomy: The "Collar" Technique. Eur Urol Focus. 2018 Sep;4(5):677-685. doi: 10.1016/j.euf.2018.01.004. Epub 2018 May 7. PMID 29402756