Urinary Bladder NeoplasmsNCT05325216
Urinary Continence of Female POPRC and OIN
A study testing POPRC+OIN and SRC+OIN in people with Urinary Bladder Neoplasms and Woman, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Urinary Bladder Neoplasms, Woman, Sexual Dysfunction, Physiological
- What is being tested?
- POPRC+OIN and SRC+OIN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong
Wenlong Zhong, 86-18510904167, zhongwlong3@mail.sysu.edu.cn
About this study
Official title: Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
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.
Read the 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
- Being tested
- POPRC+OIN, SRC+OIN
- Keywords
- Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder
- Medical subject headings
- Urinary Bladder Neoplasms, Sexual Dysfunction, Physiological, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POPRC+OINProcedure or surgery
Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
SRC+OINProcedure or surgery
Standard radical cystectomy with orthotopic ileal neobladder
| Study group | Role | What they receive |
|---|---|---|
| POPRC group | Experimental | pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder Receives: Procedure: POPRC+OIN |
| SRC group | Active comparator | standard radical cystectomy with orthotopic ileal neobladder Receives: Procedure: SRC+OIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
day-time and night-time continence rate
We will use pad-test to evaluate the urinary continence for patients
Measured: 6 months
Secondary outcomes (6)
postoperative sexual function
International index of erectile function-5 (IIEF-5)
Measured: 6 months
perioperative complications rate
perioperative complications rate within 1 month
Measured: 1 months
overall survival
5-year overall survival rate
Measured: 5 years
recurrence-free survival
5-year overall recurrence-free survival rate
Measured: 5 years
operative time
operative time (mins)
Measured: 24 hours
estimated blood loss
estimated blood loss (ml)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startApr 2022 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325216
- Sponsor's protocol ID
- 2021-KY-074
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be public access via the ResMan
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05325216
- Acronym / sponsor ID
- 2021-KY-074
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Peking University Third Hospital
- Study start
- Apr 2022 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POPRC group | Experimental | Procedure: POPRC+OINpelvic-organ preserving radical cystectomy with orthotopic ileal neobladder |
| SRC group | Active comparator | Procedure: SRC+OINstandard radical cystectomy with orthotopic ileal neobladder |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POPRC+OINPelvic-organ preserving radical cystectomy with orthotopic ileal neobladder | Procedure or surgery | POPRC group |
| SRC+OINStandard radical cystectomy with orthotopic ileal neobladder | Procedure or surgery | SRC group |
Primary outcome
day-time and night-time continence rate
Time frame: 6 months
We will use pad-test to evaluate the urinary continence for patients
6 secondary outcomes
postoperative sexual function
Time frame: 6 months
perioperative complications rate
Time frame: 1 months
overall survival
Time frame: 5 years
recurrence-free survival
Time frame: 5 years
operative time
Time frame: 24 hours
estimated blood loss
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No. IPD will be public access via the ResMan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POPRC+OIN and SRC+OIN in people with Urinary Bladder Neoplasms and Woman, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenlong Zhong, MD (86-18510904167, zhongwlong3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
day-time and night-time continence rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.