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Completed

NCT Number: NCT03613311

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

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.

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Key information

Conditions

Urodynamic Stress Incontinence in Severe Cystocele Women Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >20y/o
  • Cystocele > stage II
  • Complete urodynamic study

Exclusion criteria

  • Pregnancy
  • Urinary tract infection
  • Previous pelvic reconstruction surgery

Treatment and study plan

Urodynamic study

Diagnostic Test

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

Primary outcomes

  1. Evident USI

    Time frame: Between November 2011 and January 2017

    USI note before reduction of prolapse

  2. Occult USI

    Time frame: Between November 2011 and January 2017

    USI note after reduction of prolapse

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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