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NCT Number: NCT05558111

The 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).

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Key information

Conditions

Orthotopic Neobladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Chunxiao Liu

CONTACT

[email protected]

13302296795

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The location of brain functional activation areas

    Time frame: 3 months

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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunxiao Liu

CONTACT

[email protected]

13302296795

Yuanxing Huang

CONTACT

[email protected]

13826196384

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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