Urinary Continence of Female POPRC and OIN
Primary Purpose
Urinary Bladder Neoplasms, Woman, Sexual Dysfunction, Physiological
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
POPRC+OIN
SRC+OIN
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder
Eligibility Criteria
Inclusion Criteria:
- Female patients aged between 55-75.
- Patients those who are diagnosed with organ-confined urothelial carcinoma(<pT3)
- Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.
- ECOG score between 0-2;
- Normal renal function;
- Patients those who volunteer to participate in this study and sign the informed consents.
- Patients those who are able to cooperate in the study.
Exclusion Criteria:
- Absence of tumour in bladder neck or urethra;
- Patients thsoe who are diagnosed distant metastasis before surgery.
- Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;
- Patients those who are diagnosed with other malignancies.;
- Patients those who had received pelvic radiotherapy or major pelvic operation.
- Pregnancy status;
- Any other conditions that the researcher considers to be excluded from this study
Sites / Locations
- Sun Yat-Sen Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
POPRC group
SRC group
Arm Description
pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
standard radical cystectomy with orthotopic ileal neobladder
Outcomes
Primary Outcome Measures
day-time and night-time continence rate
We will use pad-test to evaluate the urinary continence for patients
Secondary Outcome Measures
postoperative sexual function
International index of erectile function-5 (IIEF-5)
perioperative complications rate
perioperative complications rate within 1 month
overall survival
5-year overall survival rate
recurrence-free survival
5-year overall recurrence-free survival rate
operative time
operative time (mins)
estimated blood loss
estimated blood loss (ml)
Full Information
NCT ID
NCT05325216
First Posted
April 5, 2022
Last Updated
April 12, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05325216
Brief Title
Urinary Continence of Female POPRC and OIN
Official Title
Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 1, 2028 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Woman, Sexual Dysfunction, Physiological, Treatment Outcome, Urinary Incontinence
Keywords
Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POPRC group
Arm Type
Experimental
Arm Description
pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Arm Title
SRC group
Arm Type
Active Comparator
Arm Description
standard radical cystectomy with orthotopic ileal neobladder
Intervention Type
Procedure
Intervention Name(s)
POPRC+OIN
Intervention Description
Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Intervention Type
Procedure
Intervention Name(s)
SRC+OIN
Intervention Description
Standard radical cystectomy with orthotopic ileal neobladder
Primary Outcome Measure Information:
Title
day-time and night-time continence rate
Description
We will use pad-test to evaluate the urinary continence for patients
Time Frame
6 months
Secondary Outcome Measure Information:
Title
postoperative sexual function
Description
International index of erectile function-5 (IIEF-5)
Time Frame
6 months
Title
perioperative complications rate
Description
perioperative complications rate within 1 month
Time Frame
1 months
Title
overall survival
Description
5-year overall survival rate
Time Frame
5 years
Title
recurrence-free survival
Description
5-year overall recurrence-free survival rate
Time Frame
5 years
Title
operative time
Description
operative time (mins)
Time Frame
24 hours
Title
estimated blood loss
Description
estimated blood loss (ml)
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients aged between 55-75.
Patients those who are diagnosed with organ-confined urothelial carcinoma(<pT3)
Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.
ECOG score between 0-2;
Normal renal function;
Patients those who volunteer to participate in this study and sign the informed consents.
Patients those who are able to cooperate in the study.
Exclusion Criteria:
Absence of tumour in bladder neck or urethra;
Patients thsoe who are diagnosed distant metastasis before surgery.
Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;
Patients those who are diagnosed with other malignancies.;
Patients those who had received pelvic radiotherapy or major pelvic operation.
Pregnancy status;
Any other conditions that the researcher considers to be excluded from this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenlong Zhong, MD
Phone
86-18510904167
Email
zhongwlong3@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenlong Zhong
Phone
86-18510904167
Email
zhongwlong3@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be public access via the ResMan
Learn more about this trial
Urinary Continence of Female POPRC and OIN
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