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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03613350

Collaborator

(none)

480

Enrollment

78.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptom in Severe Cystocele Women	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 Design

Study Type:

Observational

Actual Enrollment :

480 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jan 31, 2017

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

USI [Between November 2011 and January 2017]
Urodynamic stress incontinence was noted during examination
BO/DO [Between November 2011 and January 2017]
Bladder oversensitivity/detrusor overactivity was noted during examination