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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Voiding Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Women with symptoms of voiding dysfunction.

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.

Treatment and study plan

Urodynamic study

Diagnostic Test

The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position [14]. A 20-minute pad test for each woman was also performed [15, 16]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS [3]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.

Other names: Pad test

Primary outcomes

Number of Participants with Detrusor underactivity or Bladder outlet obstruction

Time frame: 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%.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Urodynamically Age-specific Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Voiding Dysfunction Without Cystocele

Important dates

Study start: 1996
Primary completion: 2018
Study completion: 2018
First posted: Dec 4, 2019
Registry last updated: Dec 9, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed