Muscle-Invasive Bladder CarcinomaNCT04966130
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
An observational study of Muscle-Invasive Bladder Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- Men only
- Adult, Older adult
Study population: Patients undergoing robot- assisted radical cystectomy with orthotopic ileal neobladder will be enrolled.
Who may be able to join
- Patients with pathologically confirmed bladder cancer
- Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder
- Complete perioperative clinical data
Who cannot join
- Patients diagnosed with distant metastasis
- Patients who had urinary incontinence before surgery
- Patients with unavailable follow-up data
Trial locations and contacts
No sites are listed yet.
About this study
The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.
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. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- muscle-invasive bladder cancer, robot-assisted radical cystectomy, urinary indwelling time, continence
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-time continence rate
Measured: 1 year
Night-time continence rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Jian Huang, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966130
- Sponsor's protocol ID
- SysMU-RARC1
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
- ClinicalTrials.gov ID
- NCT04966130
- Acronym / sponsor ID
- SysMU-RARC1
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- muscle-invasive bladder cancer, robot-assisted radical cystectomy, urinary indwelling time, continence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.
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. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing robot- assisted radical cystectomy with orthotopic ileal neobladder will be enrolled.
Key inclusion criteria (3 listed)
- Patients with pathologically confirmed bladder cancer
- Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder
- Complete perioperative clinical data
Key exclusion criteria (3 listed)
- Patients diagnosed with distant metastasis
- Patients who had urinary incontinence before surgery
- Patients with unavailable follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Day-time continence rate
Time frame: 1 year
Night-time continence rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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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. This study is not recruiting at the moment.
Jian Huang, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen (+86-02034078960, chenh585@mail2.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 continence rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 19 Jul 2021.