BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

NCT ID: NCT03613324

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

455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2018-05-31

Brief Summary

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Prevalence rates of bladder outlet obstruction (BOO) and detrusor underactivity (DU) 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.

Detailed Description

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Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Only those with complete data of maximum flow rate (Qmax) and detrusor pressure at maximum flow rate (PdetQmax) were enrolled. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O, and were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Conditions

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Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bladder outlet obstruction (BOO)

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Woman were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Detrusor underactivity (DU)

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O during voiding cystometry.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

ND BOO/DU

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. This group revealed no demonstrated bladder outlet obstruction nor detrusor underactivity.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Interventions

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Pad test

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Urodynamic study

Eligibility Criteria

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Inclusion Criteria

1. Age \> 20y/o
2. Cystocele \> stage II
3. Complete pad test and urodynamic study

Exclusion Criteria

1. Pregnancy
2. Urinary tract infection
3. Had received 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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201805025RINB

Identifier Type: -

Identifier Source: org_study_id

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