Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele

Completed

• Conditions: Voiding Disorders
• Interventions: Diagnostic Test: Urodynamic study

• Registration Number: NCT04184752
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. However, urodynamic/videourodynamic studies are invasive. The investigators are interested in whether there were specific symptoms or measurements that can be used for initial differential diagnosis between DU and BOO. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the clinical and urodynamic differences between the DU, BOO and non-DU/BOO groups.

Detailed Description

Between April 1996 and September 2018, all women with symptoms of voiding dysfunction 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 (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. Besides, women with cystocele were also excluded. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. ANOVA test with Bonferroni correction or chi-square test was used for statistical analysis as appropriate. Linear regression analysis with age adjustment was used to assess the adjusted effect of variables. P \< 0.05 was considered as statistical significant.

Study Timeline

• Study Start: 1996-04-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-08
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-04
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 602

Inclusion Criteria

• Women with symptoms of voiding dysfunction.

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Exclusion Criteria

• Cystocele
• Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder outlet obstruction	Urodynamic study	The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s.
Detrusor underactivity	Urodynamic study	The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. BVE = voided volume / (voided volume+ PVR) x 100%.
Non-DU/BOO group	Urodynamic study	Those women without DU or BOO were allocated to the non-DU/BOO group.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Detrusor underactivity or Bladder outlet obstruction	Between April 1996 and September 2018	The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan