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

Prevalence Rates of Bladder Outlet Obstruction and Detrusor Underactivity 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.

Study Overview

• Status: Completed
• Conditions: Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele
• Intervention / Treatment: Diagnostic test: Pad test

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 Type: Observational
• Enrollment (Actual): 455

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with more than stage II cystocele

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bladder outlet obstruction (BOO); 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.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.; Other Names: Urodynamic study
Detrusor underactivity (DU); 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.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.; Other Names: Urodynamic study
ND BOO/DU; 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.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.; Other Names: Urodynamic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
DU	Detrusor underactivity: <12 mL/s and PdetQmax was <10 cmH2O	November 2011 to January 2017

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Cystocele; Urodynamic study; Bladder outlet obstruction; Detrusor underactivity
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Pathological Conditions, Anatomical; Dyskinesias; Urethral Diseases; Urethral Obstruction; Pelvic Organ Prolapse; Prolapse; Hernia; Cystocele; Hypokinesia; Urinary Bladder Neck Obstruction; Urinary Bladder, Underactive
• Other Study ID Numbers: 201805025RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No