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

NCT ID: NCT03613311

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-01

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urodynamic Stress Incontinence in Severe Cystocele Women

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Evident urodynamic stress incontinence(USI)

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. 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.

Urodynamic study

Intervention Type DIAGNOSTIC_TEST

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

Occult USI

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. 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 after prolapse reduction by vaginal gauze.

Urodynamic study

Intervention Type DIAGNOSTIC_TEST

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

ND USI

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. No USI was noted in this group.

Urodynamic study

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Urodynamic study

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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201805048RIN

Identifier Type: -

Identifier Source: org_study_id

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