Trials / Not Yet Recruiting
Not Yet RecruitingNCT05325216
Urinary Continence of Female POPRC and OIN
Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 55 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Urinary Bladder Neoplasms
- Woman
- Sexual Dysfunction, Physiological
- Treatment Outcome
- Urinary Incontinence
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | POPRC+OIN | Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder |
| PROCEDURE | SRC+OIN | Standard radical cystectomy with orthotopic ileal neobladder |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2022-04-13
- Last updated
- 2022-04-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05325216. Inclusion in this directory is not an endorsement.