Orthotopic NeobladderNCT05558111
The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
An observational study of Orthotopic Neobladder, run by Zhujiang Hospital at 1 site in China.
Trial summary
Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthotopic Neobladder
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 3 months or more after orthotopic neobladder surgery.
Who may be able to join
- Being right-handed;
- 3 months or more after operation;
- No contraindications to fMIR examination;
- Voluntarily sign informed consent.
Who cannot join
- History of bladder radiotherapy;
- History of prostate cancer;
- Suffering from diseases affecting abdominal pressure;
- History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
- History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
- Claustrophobia or carrying metal implants that are not suitable for fMRI examination;
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- Diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.);
- Urethral stricture;
- Refusing to sign the informed consent form for clinical projects;
- Other conditions that were not suitable for inclusion according to the investigator's judgment.
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, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Chunxiao Liu, 13302296795, liuchx888@163.com
About this study
Official title: Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).
- Conditions
- Orthotopic Neobladder
- Keywords
- Orthotopic neobladder, Functional magnetic resonance imaging, Neuroimaging Study, Lower urinary tract function, Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with orthotopic neobladder | Patients with orthotopic neobladder who met the inclusion criteria will be enrolled.Inclusion criteria :(1) being right-handed;(2) 3 months or more after operation;(3) No contraindications to fMIR examination;(4)Does not meet the relevant exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The location of brain functional activation areas
Areas of the brain where excitation or inhibition occurs in fMRI images
Measured: 3 months
The peak T-value size of the activation region
Peak T values of activated or inhibited regions of the brain in fMRI images
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthotopic NeobladderStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxiao Liu, Zhujiang Hospital
- Investigators
- Chunxiao Liu, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558111
- Sponsor's protocol ID
- 2022-KY-131-02
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
- ClinicalTrials.gov ID
- NCT05558111
- Acronym / sponsor ID
- 2022-KY-131-02
- Conditions
- Orthotopic Neobladder
- Keywords
- Orthotopic neobladder, Functional magnetic resonance imaging, Neuroimaging Study, Lower urinary tract function, Bladder cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 28 Sep 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.
Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with orthotopic neobladder | – | –Patients with orthotopic neobladder who met the inclusion criteria will be enrolled.Inclusion criteria :(1) being right-handed;(2) 3 months or more after operation;(3) No contraindications to fMIR examination;(4)Does not meet the relevant exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 3 months or more after orthotopic neobladder surgery.
Key inclusion criteria (4 listed)
- Being right-handed;
- 3 months or more after operation;
- No contraindications to fMIR examination;
- Voluntarily sign informed consent.
Key exclusion criteria (10 listed)
- History of bladder radiotherapy;
- History of prostate cancer;
- Suffering from diseases affecting abdominal pressure;
- History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
- History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
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
The location of brain functional activation areas
Time frame: 3 months
Areas of the brain where excitation or inhibition occurs in fMRI images
The peak T-value size of the activation region
Time frame: 3 months
Peak T values of activated or inhibited regions of the brain in fMRI images
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 8 Oct 2026.
Related trials for Orthotopic Neobladder
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Urinary Continence of Female POPRC and OIN
Urinary Bladder Neoplasms, Woman
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.
Chunxiao Liu principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthotopic Neobladder, run by Zhujiang Hospital 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 Chunxiao Liu (13302296795, liuchx888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The location of brain functional activation areas (time frame: 3 months). 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 8 Oct 2026.