DU and BOO in Women With and Without Symptoms of VD

Completed

• Conditions: Detrusor Underactivity; Bladder Outlet Obstruction
• Interventions: Diagnostic Test: Urodynamic study

• Registration Number: NCT04981080
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Study Start: 2005-02-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1886

Inclusion Criteria

• Women with lower urinary tract symptoms
• Complete urodynamic study

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No symptom of voiding dysfunction	Urodynamic study	Women with lower urinary tract symptoms but without cystocele or voiding symptoms who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed
Symptom of voiding dysfunction	Urodynamic study	Women with lower urinary tract symptoms including voiding symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed

Primary Outcome Measures

Name	Time	Method
Bladder outlet obstruction	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
Detrusor underactivity	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 %

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan