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

NCT ID: NCT03613350

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 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.

Detailed Description

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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.

Conditions

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Lower Urinary Tract Symptom 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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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.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

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.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

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.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

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.

Pad test

Intervention Type DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

Interventions

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Pad test

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

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. 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
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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201805024RINB

Identifier Type: -

Identifier Source: org_study_id

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