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

Prostate Cancer Clinical Trial

Official title:

Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037800
• Other study ID #: CH-URO2019001
• Status: Completed
• Phase: N/A
• Start date: December 8, 2019
• Est. completion date: September 28, 2021

Study information

• Verified date: May 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 28, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Procedure:
• SFUR-RARP
Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
• Standard RARP
Robotic-assisted radical prostatectomy with conventional RARP procedures.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Post-operative sexual function	Sexual Health Inventory for Men (SHIM) score >=17.	1-year from the intervention
Primary	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	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
Secondary	Peri and postoperative complications	Clavien-Dindo classification.	1-year follow up
Secondary	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
Secondary	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.