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RecruitingNCT05558111Updated Dec 4, 2024

The Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.

An observational study in Orthotopic Neobladder, sponsored by Zhujiang Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Zhujiang Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Orthotopic Neobladder

Keywords

  • Orthotopic neobladder
  • Functional magnetic resonance imaging
  • Neuroimaging Study
  • Lower urinary tract function
  • Bladder cancer
03

In context

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients 3 months or more after orthotopic neobladder surgery.

Inclusion criteria

  1. Being right-handed;
  2. 3 months or more after operation;
  3. No contraindications to fMIR examination;
  4. Voluntarily sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. History of bladder radiotherapy;
  2. History of prostate cancer;
  3. Suffering from diseases affecting abdominal pressure;
  4. History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
  5. History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
  6. Claustrophobia or carrying metal implants that are not suitable for fMRI examination;
  7. Diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.);
  8. Urethral stricture;
  9. Refusing to sign the informed consent form for clinical projects;
  10. Other conditions that were not suitable for inclusion according to the investigator's judgment.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. The location of brain functional activation areas

    Areas of the brain where excitation or inhibition occurs in fMRI images

    Time frame: 3 months

  2. The peak T-value size of the activation region

    Peak T values of activated or inhibited regions of the brain in fMRI images

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05558111
Lead sponsor
Zhujiang Hospital
Responsible party
Chunxiao Liu (Professor;Chief Surgeon, Zhujiang Hospital) — Principal investigator
First posted
Sep 28, 2022
Start date
Jun 1, 2022
Primary completion
Jan 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Dec 4, 2024

Study contacts

Chunxiao Liu
Contact
liuchx888@163.com
13302296795
Yuanxing Huang
Contact
852691657@qq.com
13826196384
Chunxiao Liu
principal investigator · Southern Medical University, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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