An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction

NCT04037800 | Completed DMC

• 1 other identifier: CH-URO2019001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Urinary Incontinence

Keywords

Prostate cancer; Prostatectomy; Robotic surgery; Urinary incontinence; Sustainable functional urethral reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Short-term urinary continence recovery

  Within 3 month after catheter removal

• Peri and postoperative complications

  1-year follow up

• Post-operative oncological outcomes

  1-year follow up

• Short-term urinary function and urinary function-related quality of life

  1-week, 2-week, 1-month, 3-month after catheter removal.

Other Outcomes (4)

• 1-year urinary continence recovery

  1-year from the intervention

• 1-year urinary function and urinary function-related quality of life

  1-year from the intervention

• Evaluation of urinary continence with ICIQ-UI-SF

  1-week, 2-week, 1-month, 3-month after catheter removal

Study Arms (2)

SFUR-RARP

EXPERIMENTAL

Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.

Procedure: SFUR-RARP

Standard RARP

ACTIVE COMPARATOR

Patients in which standard RARP is performed.

Procedure: Standard RARP

Interventions

SFUR-RARP PROCEDURE

Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)

SFUR-RARP

Standard RARP PROCEDURE

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Standard RARP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Related Publications (5)

• 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.

  PMID: 22749852 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.

  PMID: 22270136 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.

  PMID: 27484205 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.

  PMID: 28319318 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.

  PMID: 29402756 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yinghao Sun, MD, PHD

  Changhai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: December 8, 2019
• Primary Completion: January 10, 2021
• Study Completion: September 28, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)