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OpenTrials
Completed

NCT Number: NCT03613350

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

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.

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Key information

Conditions

Lower Urinary Tract Symptom in Severe Cystocele Women Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >20y/o
  • Severe cystocele, ie, more than stage 2
  • Complete pad test and urodynamic study

Exclusion criteria

  • Pregnancy
  • Urinary tract infection
  • Had received pelvic reconstruction

Treatment and study plan

Pad test

Diagnostic Test

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

Other names: urodynamic study

Primary outcomes

  1. USI

    Time frame: Between November 2011 and January 2017

    Urodynamic stress incontinence was noted during examination

  2. BO/DO

    Time frame: Between November 2011 and January 2017

    Bladder oversensitivity/detrusor overactivity was noted during examination

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Prevalence Rates of Urodynamic Stress Incontinence, Bladder Oversensitivity/Detrusor Overactivity or Both 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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