Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changhai Hospital
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- 1-month urinary continence recovery rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
SFUR-RARP
Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.
Intervention: SFUR-RARP (Procedure)
Standard RARP
Patients in which standard RARP is performed.
Intervention: Standard RARP (Procedure)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Yinghao Sun
Chief Physician
Changhai Hospital