Prevalence Rates of USI, BO, DO and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Prevalence Rates of Urodynamic Stress Incontinence, Bladder Oversensitivity/Detrusor Overactivity or Both and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Prevalence rates of urodynamic stress incontinence (USI), bladder oversensitivity (BO) /detrusor overactivity (DO) or both 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: Lower Urinary Tract Symptom in Severe Cystocele Women
• 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-minute pad testing and urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction. BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Those women without USI, BO or DO were allocated into the no demonstrated USI+BO/DO group.

• Study Type: Observational
• Enrollment (Actual): 480

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 ≥stage II cystocele.

Description

Inclusion Criteria:

1. Age >20y/o
2. Severe cystocele, ie, more than stage 2
3. Complete pad test and urodynamic study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urodynamic stress incontinence; Urodynamic study incontinence Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Names: urodynamic study
USI+BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Names: urodynamic study
BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Names: urodynamic study
No demonstrated USI+BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. No urodynamic stress incontinence, no bladder oversensitivity nor detrusor overactivity was noted in this group.	Diagnostic test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Names: urodynamic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
USI	Urodynamic stress incontinence was noted during examination	Between November 2011 and January 2017
BO/DO	Bladder oversensitivity/detrusor overactivity was noted during examination	Between November 2011 and January 2017

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2011
• Primary Completion (ACTUAL): January 31, 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; Pad test; Urodynamic stress incontinence; Detrusor overactivity
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Hernia; Lower Urinary Tract Symptoms; Cystocele
• Other Study ID Numbers: 201805024RINB

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