Prostate Cancer, Urinary Incontinence
Conditions
Keywords
Prostate cancer, Prostatectomy, Robotic surgery, Urinary incontinence, Sustainable functional urethral reconstruction
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.
Interventions
PROCEDURESFUR-RARP
Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
PROCEDUREStandard RARP
Robotic-assisted radical prostatectomy with conventional RARP procedures.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-month urinary continence recovery rates | 1 month after catheter removal | Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term urinary continence recovery | 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. |
| Peri and postoperative complications | 1-year follow up | Clavien-Dindo classification. |
| Post-operative oncological outcomes | 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). |
| Short-term urinary function and urinary function-related quality of life | 1-week, 2-week, 1-month, 3-month after catheter removal. | International Prostatic Symptom Score(IPSS) and the IPSS quality of life score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 1-year urinary function and urinary function-related quality of life | 1-year from the intervention | International Prostatic Symptom Score(IPSS) and the IPSS quality of life score. |
| Evaluation of urinary continence with ICIQ-UI-SF | 1-week, 2-week, 1-month, 3-month after catheter removal | International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF). |
| Post-operative sexual function | 1-year from the intervention | Sexual Health Inventory for Men (SHIM) score \>=17. |
| 1-year urinary continence recovery | 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. |
Countries
China
Outcome results
None listed