Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele

Urodynamic Stress Incontinence in Severe Cystocele Women Clinical Trial

Official title:

Prevalence Rates of Evident, Occult and no Demonstrated Urodynamic Stress Incontinence and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613311
• Other study ID #: 201805048RIN
• 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 urinary incontinence (USI) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation, especially for occult USI. Misdiagnosis of occult USI before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair. 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 urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. The recruited patients with cystocele were classified into three groups (i.e.,evident USI, occult USI and no demonstrated USI) according to pad weight results before and after prolapse reduction.

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. Cystocele > stage II

3. Complete urodynamic study

Exclusion Criteria:

1. Pregnancy

2. Urinary tract infection

3. Previous pelvic reconstruction surgery

Related Conditions & MeSH terms

• Cystocele
• Hernia
• Urinary Incontinence, Stress
• Urodynamic Stress Incontinence in Severe Cystocele Women

Intervention

Diagnostic Test:
• Urodynamic study
Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile

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	Evident USI	USI note before reduction of prolapse	Between November 2011 and January 2017
Primary	Occult USI	USI note after reduction of prolapse	Between November 2011 and January 2017