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Recruiting NCT05558111

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

Observational Orthotopic Neobladder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Orthotopic Neobladder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Primary outcome measures

  • The location of brain functional activation areas [Time frame: 3 months]
  • The peak T-value size of the activation region [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhujiang Hospital of Southern Medical University — Guangzhou

Identifiers

NCT: NCT05558111 · 2022-KY-131-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗