Female LUTS and Quality of Life

Correlation Analysis of Quality of Life With Different Groups of Female Lower Urinary Tract Symptoms Based on Bladder Diary

Storage symptoms include frequency, urgency, nocturia and incontinence. Based on bladder diaries, we could get the objective data of the above symptoms. To the best of our knowledge, there is lack of correlation of quality of life with lower urinary tract symptoms based on bladder diaries. Thus, we aimed to perform the study.

Study Overview

• Status: Completed
• Conditions: Bladder Diary
• Intervention / Treatment: Diagnostic test: Bladder diary

Detailed Description

The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with at least one episode of urgency and urinary incontinence (UI) were allocated to the overactive bladder syndrome (OAB) -wet group. Women with at least one episode of urgency but without incontinence were allocated to the OAB-dry group. Women with at least one episode of UI but without urgency were allocated to the UI group. Women with more or equal to 2 episodes of nocturia but without urgency and UI were allocated to the nocturia group. Women with more or equal to 8 episodes of daytime frequency but without urgency, UI and nocturia were allocated to the frequency group. Otherwise, normal group. Analysis of variance with Bonferroni correction was used to perform statistical analysis for between-group comparisons.

• Study Type: Observational
• Enrollment (Actual): 2953

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with lower urinary tract symptoms completed a 3-day bladder diary and King's Health Questionnaire.

Description

Inclusion Criteria:

• Women with lower urinary tract symptoms
• Finish 3-day bladder diary
• Finish King's Health Questionnaire

Exclusion Criteria:

• Incomplete data
• Pregnant women
• Urinary tract infection, acute or chronic
• History of pelvic malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OAB-wet; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with at least one episode of urgency and urinary incontinence (UI) were allocated to the overactive bladder syndrome (OAB) -wet group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
OAB-dry; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with at least one episode of urgency but without incontinence were allocated to the OAB-dry group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
UI; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with at least one episode of UI but without urgency were allocated to the UI group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
Nocturia; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with more or equal to 2 episodes of nocturia but without urgency and UI were allocated to the nocturia group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
Frequency; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with more or equal to 8 episodes of daytime frequency but without urgency, UI and nocturia were allocated to the frequency group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
Normal; The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women without urgency, UI, nocturia nor frequency were allocated to the normal group.	Diagnostic test: Bladder diary; A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finish quality of life accessment	Quality of life was accessed by King's Health Questionnaire	January 2010 to December 2019

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
• Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.
• Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15.
• Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20.
• Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2010
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Lower urinary tract symptoms
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 202006086RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared under reasonable request

Drug and device information, study documents

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