An interventional study of POPRC+OIN and SRC+OIN in Urinary Bladder Neoplasms, Woman and Sexual Dysfunction, Physiological, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to female participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Procedure: POPRC+OIN
standard radical cystectomy with orthotopic ileal neobladder
Procedure: SRC+OIN
Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Standard radical cystectomy with orthotopic ileal neobladder
day-time and night-time continence rate
We will use pad-test to evaluate the urinary continence for patients
Time frame: 6 months
postoperative sexual function
International index of erectile function-5 (IIEF-5)
Time frame: 6 months
perioperative complications rate
perioperative complications rate within 1 month
Time frame: 1 months
overall survival
5-year overall survival rate
Time frame: 5 years
recurrence-free survival
5-year overall recurrence-free survival rate
Time frame: 5 years
operative time
operative time (mins)
Time frame: 24 hours
estimated blood loss
estimated blood loss (ml)
Time frame: 24 hours
Plan to share: No — IPD will be public access via the ResMan
No publications or documents are linked to this record.
Start is estimated for Apr 2022; primary completion for Apr 2028, 72 months later.
Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's planned 72 months is above that.
Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.
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This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →