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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037800
Recruitment Status : Unknown
Verified December 2019 by Yinghao Sun, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : July 30, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yinghao Sun, Changhai Hospital

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Incontinence Procedure: SFUR-RARP Procedure: Standard RARP Not Applicable

Detailed Description:
Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 12 months after operation. Many urologists are trying to improve the surgery, but these new technics mainly help locally advanced prostate cancer by better preserving Neurovascular Bundles, urethra, external sphincter or other periurethral supporting structures. Sustainable functional urethral reconstruction (SFUR) is a novel technic which can improve early urinary incontinence for both locally and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and sustainable periurethral support with peritoneal flap. The purpose of this study is to compare early continence recovery, oncologic outcomes and postoperative complications after RARP with or without this new technic.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Sustainable Functional Urethral Reconstruction(SFUR) for Robotic-assisted Laparoscopic Radical Prostatectomy(RARP) on Short-term Continence Recovery: a Randomized Controlled Trial
Actual Study Start Date : December 8, 2019
Estimated Primary Completion Date : October 8, 2020
Estimated Study Completion Date : April 8, 2021

Resource links provided by the National Library of Medicine


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 without sustainable functional urethral reconstruction (SFUR)




Primary Outcome Measures :
  1. Early urinary continence recovery [ Time Frame: 1 month after the removal of the urinary catheter ]
    Number of pads and 24-hour pad weights(Patients with 0 pad/one security liner per day(24-hour pad weights≤50g ) shall be regarded continence)


Secondary Outcome Measures :
  1. Early urinary continence recovery [ Time Frame: one day, 2 weeks and 1 month after catheter removal ]
    Two definitions shall be used: Number of pads(Patients with 0 pad/one security liner per day(24-hour pad weights≤50g ) shall be regarded continence) and early urinary recovery quantification in Grams (PAD-test 24h)

  2. Urinary continence recovery [ Time Frame: within 3/6/12 months from the intervention ]
    Two definitions shall be used: 0 pad/one security liner per day(24-hour pad weights≤50g), and 0 pad per day

  3. Peri and postoperative complications [ Time Frame: 6-month/1-year median follow up ]
    Clavien-Dindo complications

  4. Post-operative oncological outcomes, as defined by post-operative Prostate-Specific antigen (PSA) value [ Time Frame: 1-year median follow up ]
    Patients who reach a post-operative PSA value <0.2 ng/ml will be reported

  5. Evaluation of urinary incontinence [ Time Frame: before surgery, 1 month after catheter removal, 3/6/12 months after surgery ]
    International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF)

  6. Post-operative urinary function and urinary function-related quality of life [ Time Frame: before surgery, 3/6/12 months after surgery ]
    International Prostatic Symptom Score(IPSS)

  7. Post-operative sexual function, as measured by Sexual Health Inventory for Men (SHIM) [ Time Frame: 6-month/1-year median follow up ]
    Two definitions of potency shall be used: SHIM >=17 and erections sufficient for penetrative intercourse



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037800


Contacts
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Contact: Xu Gao, MD, PHD 86-021-31161718 gaoxu.changhai@foxmail.com
Contact: Zepeng Jia zepengjia@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200082
Contact: Xu Gao, MD, PHD    86-021-31161718    gaoxu.changhai@foxmail.com   
Contact: Zepeng Jia    +8616628766616    zepengjia@163.com   
Principal Investigator: Xu Sun, MD, PHD         
Principal Investigator: Xu Gao, MD, PHD         
Sponsors and Collaborators
Changhai Hospital
Investigators
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Study Chair: Yinghao Sun, MD, PHD Changhai Hospital
Publications:
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Responsible Party: Yinghao Sun, Chief Physician, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04037800    
Other Study ID Numbers: CH-URO2019001
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yinghao Sun, Changhai Hospital:
Prostate cancer
Prostatectomy
Robotic surgery
Urinary incontinence
Sustainable functional urethral reconstruction
Additional relevant MeSH terms:
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Prostatic Neoplasms
Urinary Incontinence
Enuresis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders