Changhai Hospital
Shanghai, Shanghai Municipality, 200082, China
NCT Number: NCT04037800
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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Notify Me40 year–75 year
Male
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200082, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
Robotic-assisted radical prostatectomy with conventional RARP procedures.
Time frame: 1 month after catheter removal
Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.
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.
Time frame: 1-year follow up
Clavien-Dindo classification.
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).
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.
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.
Time frame: 1-year from the intervention
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
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF).
Time frame: 1-year from the intervention
Sexual Health Inventory for Men (SHIM) score >=17.
Changhai Hospital
Other
Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial
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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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