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OpenTrials
Completed

NCT Number: NCT04037800

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

SFUR-RARP

Procedure

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

Standard RARP

Procedure

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Primary outcomes

  1. 1-month urinary continence recovery rates

    Time frame: 1 month after catheter removal

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

Secondary outcomes

  1. Short-term urinary continence recovery

    Time frame: Within 3 month after catheter removal

    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.

  2. Peri and postoperative complications

    Time frame: 1-year follow up

    Clavien-Dindo classification.

  3. Post-operative oncological outcomes

    Time frame: 1-year follow up

    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).

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

    Time frame: 1-week, 2-week, 1-month, 3-month after catheter removal.

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

Other outcomes

  1. 1-year urinary continence recovery

    Time frame: 1-year from the intervention

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

  2. 1-year urinary function and urinary function-related quality of life

    Time frame: 1-year from the intervention

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

  3. Evaluation of urinary continence with ICIQ-UI-SF

    Time frame: 1-week, 2-week, 1-month, 3-month after catheter removal

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

  4. Post-operative sexual function

    Time frame: 1-year from the intervention

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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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