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

Primary Purpose

Prostate Cancer, Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SFUR-RARP

Standard RARP

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Prostatectomy, Robotic surgery, Urinary incontinence, Sustainable functional urethral reconstruction

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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;

Sites / Locations

Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SFUR-RARP

Standard RARP

Arm Description

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

Patients in which standard RARP is performed.

Outcomes

Primary Outcome Measures

1-month urinary continence recovery rates

Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.

Secondary Outcome Measures

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.

Peri and postoperative complications

Clavien-Dindo classification.

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).

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

International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.

Full Information

NCT ID

NCT04037800

First Posted

July 24, 2019

Last Updated

May 11, 2022

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04037800

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 8, 2019 (Actual)

Primary Completion Date

January 10, 2021 (Actual)

Study Completion Date

September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Urinary Incontinence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SFUR-RARP

Arm Type

Experimental

Arm Description

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

Arm Title

Standard RARP

Arm Type

Active Comparator

Arm Description

Patients in which standard RARP is performed.

Intervention Type

Procedure

Intervention Name(s)

SFUR-RARP

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard RARP

Intervention Description

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Primary Outcome Measure Information:

Title

1-month urinary continence recovery rates

Description

Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.

Time Frame

1 month after catheter removal

Secondary Outcome Measure Information:

Title

Short-term urinary continence recovery

Description

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.

Time Frame

Within 3 month after catheter removal

Title

Peri and postoperative complications

Description

Clavien-Dindo classification.

Time Frame

1-year follow up

Title

Post-operative oncological outcomes

Description

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).

Time Frame

1-year follow up

Title

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

Description

International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

1-year urinary continence recovery

Description

Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day.

Time Frame

1-year from the intervention

Title

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

Description

International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.

Time Frame

1-year from the intervention

Title

Evaluation of urinary continence with ICIQ-UI-SF

Description

International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF).

Time Frame

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

Title

Post-operative sexual function

Description

Sexual Health Inventory for Men (SHIM) score >=17.

Time Frame

1-year from the intervention

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yinghao Sun, MD, PHD

Organizational Affiliation

Changhai Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Changhai Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200082

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22749852

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.

Results Reference

background

PubMed Identifier

22270136

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.

Results Reference

background

PubMed Identifier

27484205

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.

Results Reference

background

PubMed Identifier

28319318

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.

Results Reference

background

PubMed Identifier

29402756

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.

Results Reference

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

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