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

Completed

• Conditions: Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele
• Interventions: Diagnostic Test: Pad test

• Registration Number: NCT03613324
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2017-11-30
• Study Completion: 2018-05-31
• Status Verified: 2018-07
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 455

Inclusion Criteria

1. Age > 20y/o
2. Cystocele > stage II
3. Complete pad test and urodynamic study

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Exclusion Criteria

1. Pregnancy
2. Urinary tract infection
3. Had received pelvic reconstruction surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder outlet obstruction (BOO)	Pad test	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. Woman were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.
Detrusor underactivity (DU)	Pad test	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. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O during voiding cystometry.
ND BOO/DU	Pad test	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. This group revealed no demonstrated bladder outlet obstruction nor detrusor underactivity.

Primary Outcome Measures

Name	Time	Method
BOO	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.
DU	November 2011 to January 2017	Detrusor underactivity: \<12 mL/s and PdetQmax was \<10 cmH2O