Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
NCT Number: NCT05325216
To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.
Trial opening soon.
Get Notified55 year–75 year
Female
Interventional
Not applicable
Guangzhou, Guangdong, China
Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life.
For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Standard radical cystectomy with orthotopic ileal neobladder
Time frame: 6 months
We will use pad-test to evaluate the urinary continence for patients
Time frame: 6 months
International index of erectile function-5 (IIEF-5)
Time frame: 1 months
perioperative complications rate within 1 month
Time frame: 5 years
5-year overall survival rate
Time frame: 5 years
5-year overall recurrence-free survival rate
Time frame: 24 hours
operative time (mins)
Time frame: 24 hours
estimated blood loss (ml)
Contact information is provided by the study sponsor or research team.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
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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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