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

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).

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Prostate Cancer
• Intervention / Treatment: Procedure: SFUR-RARP; Procedure: Standard RARP

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200082
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SFUR-RARP; Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.	Procedure: SFUR-RARP; Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
ACTIVE_COMPARATOR: Standard RARP; Patients in which standard RARP is performed.	Procedure: Standard RARP; Robotic-assisted radical prostatectomy with conventional RARP procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2019
• Primary Completion (ACTUAL): January 10, 2021
• Study Completion (ACTUAL): September 28, 2021

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 27, 2019
• First Posted (ACTUAL): July 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Urinary incontinence; Prostate cancer; Robotic surgery; Prostatectomy; Sustainable functional urethral reconstruction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Urination Disorders; Elimination Disorders; Prostatic Neoplasms; Urinary Incontinence; Enuresis
• Other Study ID Numbers: CH-URO2019001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No