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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).
Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFUR-RARP | Experimental | Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed. |
|
| Standard RARP | Active Comparator | Patients in which standard RARP is performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFUR-RARP | Procedure | Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-month urinary continence recovery rates | Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g. | 1 month after catheter removal |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term urinary continence recovery | Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day. Besides, quantification of urine leakage with 24-hour pad weight. | Within 3 month after catheter removal |
| Peri and postoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year urinary continence recovery | Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day. | 1-year from the intervention |
| 1-year urinary function and urinary function-related quality of life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yinghao Sun, MD, PHD | Changhai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200082 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22749852 | Background | Ficarra 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. | |
| 22270136 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Standard RARP | Procedure | Robotic-assisted radical prostatectomy with conventional RARP procedures. |
|
Clavien-Dindo classification. |
| 1-year follow up |
| Post-operative oncological outcomes | Two assessment methods: positive surgical margin (PSM) rates and 1-year biochemical recurrence-free survival (BFS, defined as two consecutive PSA levels>0.2 ng/mL). | 1-year follow up |
| Short-term urinary function and urinary function-related quality of life | International Prostatic Symptom Score(IPSS) and the IPSS quality of life score. | 1-week, 2-week, 1-month, 3-month after catheter removal. |
International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.
| 1-year from the intervention |
| Evaluation of urinary continence with ICIQ-UI-SF | International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF). | 1-week, 2-week, 1-month, 3-month after catheter removal |
| Post-operative sexual function | Sexual Health Inventory for Men (SHIM) score >=17. | 1-year from the intervention |
| Background |
| Dev 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. |
| 27484205 | Background | Bessede 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. |
| 28319318 | Background | Pavlovich 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. |
| 29402756 | Background | Bianchi 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |