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

Lower Urinary Tract Symptom in Severe Cystocele Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613350
• Other study ID #: 201805024RINB
• Status: Completed
• Start date: November 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: May 31, 2018
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Hernia
• Lower Urinary Tract Symptom in Severe Cystocele Women
• Lower Urinary Tract Symptoms

Intervention

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.

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