Clinical trial NCT04037800: An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction
Official title: Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Keywords: Prostate cancer
Prostatectomy
Robotic surgery
Urinary incontinence
Sustainable functional urethral reconstruction
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 96
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: 1-month urinary continence recovery rates
timeFrame: 1 month after catheter removal
Secondary outcomes:
measure: Short-term urinary continence recovery
timeFrame: Within 3 month after catheter removal
measure: Peri and postoperative complications
timeFrame: 1-year follow up
measure: Post-operative oncological outcomes
timeFrame: 1-year follow up
measure: Short-term urinary function and urinary function-related quality of life
timeFrame: 1-week, 2-week, 1-month, 3-month after catheter removal.
Other outcomes:
measure: 1-year urinary continence recovery
timeFrame: 1-year from the intervention
measure: 1-year urinary function and urinary function-related quality of life
timeFrame: 1-year from the intervention
measure: Evaluation of urinary continence with ICIQ-UI-SF
timeFrame: 1-week, 2-week, 1-month, 3-month after catheter removal
measure: Post-operative sexual function
timeFrame: 1-year from the intervention
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Yinghao Sun, MD, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.