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OpenTrials
Completed

NCT Number: NCT04981080

DU and BOO in Women With and Without Symptoms of VD

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity or bladder outlet obstruction. However, the prevalence of detrusor underactivity and bladder outlet obstruction remained obscure. Thus, the aim of this study was to elucidate the prevalence of detrusor underactivity and bladder outlet obstruction in women with and without symptoms of voiding dysfunction.

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Key information

About this study

Between February 2005 and December 2020, all women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate, voided volume, post-void residual volume and detrusor pressure at maximum flow rate were excluded from this study. Detrusor underactivity was defined when the detrusor pressure at maximum flow rate was less than 20 cmH2O, the maximum flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %. Bladder outlet obstruction was defined when the the detrusor pressure at maximum flow rate was not less than 40 cmH2O, and the maximum flow rate was less than 12 mL/s. Those women without detrusor interactivity or bladder outlet obstruction were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression test were used for statistical analysis as appropriate. A p < 0.05 was considered as statistically significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with lower urinary tract symptoms
  • Complete urodynamic study

Exclusion criteria

  • Advanced cystocele
  • After surgery for cystocele repair
  • Chronic infection
  • Incomplete data

Treatment and study plan

Urodynamic study

Diagnostic Test

The urodynamic assessment, including noninstrumented uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and urethral pressure profilometry, was performed with the patient in a sitting position according to the recommendations by the International Continence Society.

Primary outcomes

  1. Detrusor underactivity

    Time frame: February 2005 and December 2020

    The detrusor pressure when maximal flow rate was less than 20 cmH2O, the maximal flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %

  2. Bladder outlet obstruction

    Time frame: February 2005 and December 2020

    The detrusor pressure when maximal flow rate was not less than 40 cmH2O, and the maximal flow rate was less than 12 mL/s

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Women With and Without Symptoms of Voiding Dysfunction

Important dates

Study start
2005
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

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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