Clinical Trials Directory

Trials / Completed

CompletedNCT04981080

DU and BOO in Women With and Without Symptoms of VD

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,886 (actual)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
Female
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTUrodynamic studyThe 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.

Timeline

Start date
2005-02-01
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2021-07-28
Last updated
2021-07-28

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04981080. Inclusion in this directory is not an endorsement.

DU and BOO in Women With and Without Symptoms of VD (NCT04981080) · Clinical Trials Directory