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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 623

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with OAB who completed a 3-day bladder diary and underwent urodynamic studies at the urogynecologic outpatient clinics of the Department of Obstetrics and Gynecology of a medical center

Description

Inclusion Criteria:

1. The diagnosis of overactive bladder disease
2. Female patient of more than 20 year-old

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the difference of urodynamic parameters between OAB-wet and OAB-dry	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	1 week
Compare the difference of bladder diary parameters between OAB-wet and OAB-dry	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	1 week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2014
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): April 5, 2018

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Urodynamics; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 201404012RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No