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Completed

NCT Number: NCT03560778

Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients

A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also independent predictors for OAB-wet, and the above might indicate that OAB-wet and OAB-dry have at least partly different underlying pathophysiologies.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–99 year

Sex eligibility

Female

Study type

Observational

About this study

Aims: To identify factors predicting the presence of OAB-wet and to further derive the underlying pathophysiology in OAB-wet vs. OAB-dry.

Methods: Between September 2007 and September 2013, the medical records of women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed. Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The diagnosis of overactive bladder disease
  • Female patient of more than 20 year-old

Exclusion criteria

  • Dominant symptoms with stress urinary incontinence (SUI)
  • Regular urethral catheterization or intermittent self-catheterization
  • Urinary tract infection or chronic inflammation in the previous 2 weeks
  • Bladder calculus
  • A history of pelvic radiotherapy
  • A preexisting malignant pelvic tumor.

Treatment and study plan

Primary outcomes

  1. Compare the difference of urodynamic parameters between OAB-wet and OAB-dry

    Time frame: 1 week

    The variables of urodynamic study included maximum flow rate, average flow rate, voided volume, volume of strong to desire, detrusor pressure at maximum flow during voiding cystometry (PdetQmax), Valsalva leak point pressure (VLPP), maximal urethral pressure (MUP), maximal urethral closure pressure (MUCP), functional profile length, urethral closure pressure area (UCPA), continence length, continence area, pressure transmission ratio (PTR) at MUP, and electromyography (EMG). The urodynamic parameters will be interpreted together to get a complete urodynamic report and diagnosis, thus to compare the difference between OAB-wet and OAB-dry

  2. Compare the difference of bladder diary parameters between OAB-wet and OAB-dry

    Time frame: 1 week

    The 3-day bladder diary parameters included maximum daytime voided volume excluding the morning void derived from 3-day bladder diaries (DVVmax), urgency episodes, urgency incontinence episodes, daytime frequency, nocturia, total voided volume and total water intake. The bladder diary parameters will be interpreted together to get a complete report, such as urinary urgency and nocturia, thus to compare the difference between OAB-wet and OAB-dry

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: OAB

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Jun 26, 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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