Skip to main content
OpenTrials
Completed

NCT Number: NCT03613324

BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Prevalence rates of bladder outlet obstruction (BOO) and detrusor underactivity (DU) and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse 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 and older

Sex eligibility

Female

Study type

Observational

About this study

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Only those with complete data of maximum flow rate (Qmax) and detrusor pressure at maximum flow rate (PdetQmax) were enrolled. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. Woman were defined as having DU when Qmax was <12 mL/s and PdetQmax was <10 cmH2O, and were defined as having BOO when Qmax was <12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 20y/o
  • Cystocele > stage II
  • Complete pad test and urodynamic study

Exclusion criteria

  • Pregnancy
  • Urinary tract infection
  • Had received pelvic reconstruction surgery

Treatment and study plan

Pad test

Diagnostic Test

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Other names: Urodynamic study

Primary outcomes

  1. BOO

    Time frame: November 2011 to January 2017

    Bladder outlet obstruction: Qmax was <12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

  2. DU

    Time frame: November 2011 to January 2017

    Detrusor underactivity: <12 mL/s and PdetQmax was <10 cmH2O

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Prevalence Rates of Bladder Outlet Obstruction and Detrusor Underactivity and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Aug 3, 2018

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.

Related clinical trials

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