Quality, Cost and Treatment Success on Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination

NCT05809154 | Withdrawn

• 1 other identifier: UroLUTS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Modern clinical examinations like urodynamics allow for patient tailored treatment strategies. Urodynamics however, even if minimal invasive, may lead to urinary tract infections and are very expensive4. Aim of this study is to evaluate in the long-term perspective what patients profit of urodynamic examinations and in what patients the investigators could resign to perform urodynamics in the future and or in what patients the interval of urodynamics could be extended. Main objective is to follow in a long-term prospective cohort study, patients suffering of lower urinary tract dysfunction (LUTD). In this observational study the investigators will include all patient undergoing clinical routine urodynamic examination to better address what is the normal course of LUTD with and without Treatment. The aim is to have a prospective urodynamics database allowing to answer questions related to urodynamics.

Conditions

Urodynamics; Lower Urinary Tract Symptoms; Neurogenic Bladder

Keywords

Urodynamics; Lower Urinary Tract Symptoms; Neurogenic Bladder

Outcome Measures

Primary Outcomes (4)

• Number of voids per 24 hours

  Number of voids per 24 hours

  At the urodynamic assessment, up to 24 hours

• Number of leakages per 24 hours

  Number of leakages per 24 hours

  At the urodynamic assessment, up to 24 hours

• Number of used pads per 24 hours

  Number of used pads per 24 hours

  At the urodynamic assessment, up to 24 hours

• Post void residual (mL)

  Residual urine remaining in the bladder after voiding.

  At the urodynamic assessment, up to 10-30 minutes

Secondary Outcomes (12)

• Cystometric capacity (mL)

  At the urodynamic assessment, up to 10-30 minutes

• Compliance (mL/cmH2O)

  At the urodynamic assessment, up to 10-30 minutes

• Bladder volume (mL) at detrusor overactivity

  At the urodynamic assessment, up to 10-30 minutes

• Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity

  At the urodynamic assessment, up to 10-30 minutes

• Detrusor leak point pressure (cmH2O)

  At the urodynamic assessment, up to 10-30 minutes

Study Arms (4)

Neurogenic lower urinary tract dysfunction

Lower urinary tract dysfunction due to any neurological condition like spinal cord injury, multiple sclerosis and others.

Diagnostic Test: Video-Urodynamics

Non-Neurogenic lower urinary tract dysfunction

Lower urinary tract dysfunction in absence of any neurological pathology.

Diagnostic Test: Video-Urodynamics

Chronic pelvic pain

Chronic pelvic pain as defined by the EAU guidelines.

Diagnostic Test: Video-Urodynamics

Urodynamic normal Bladder function

Normal urodynamic findings and absence of chronic pelvic pain.

Diagnostic Test: Video-Urodynamics

Interventions

Video-Urodynamics DIAGNOSTIC_TEST

Minimal invasive Urodynamic examination: Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase. By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system. The pelvic floor muscle activity is assessed at the same time using EMG surface electrodes.

Chronic pelvic pain; Neurogenic lower urinary tract dysfunction; Non-Neurogenic lower urinary tract dysfunction; Urodynamic normal Bladder function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical indication for routine urodynamic assessment will be included in to this prospective cohort study. All standard urodynamic results as well as the treatment decision will be collected. Patients undergoing repeated urodynamic measurements i.e. spinal cord injured patients with yearly assessments will each time be included allowing for long-term and follow up analysis of both disease progress and therapy success.

You may qualify if:

• Female and male patients, age \>18 years
• Informed consent
• Lower urinary tract symptoms
• Planned clinical routine urodynamic examination

You may not qualify if:

• Age \<18 years
• Pregnancy or breast feeding
• Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences https://www.samw.ch/en/Publications/Medical-ethical-Guidelines.html)
• No informed consent
• Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marc P Schneider, MD, PhD

  Universitätsklinik für Urologie

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: April 12, 2023
• Study Start: January 1, 2019
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share