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

Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613324
• Other study ID #: 201805025RINB
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: May 31, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age > 20y/o

2. Cystocele > stage II

3. Complete pad test and urodynamic study

Exclusion Criteria:

1. Pregnancy

2. Urinary tract infection

3. Had received pelvic reconstruction surgery

Related Conditions & MeSH terms

• Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele
• Cystocele
• Hernia
• Hypokinesia
• Urinary Bladder Neck Obstruction

Intervention

Diagnostic Test:
• Pad test
20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOO	Bladder outlet obstruction: Qmax was <12 mL/s and PdetQmax was =25 cmH2O with sustained detrusor contraction during voiding cystometry.	November 2011 to January 2017
Primary	DU	Detrusor underactivity: <12 mL/s and PdetQmax was <10 cmH2O	November 2011 to January 2017