Female LUTS and Quality of Life

NCT04547933 | Completed

• 1 other identifier: 202006086RIND
• Study Type: observational
• Target: 2,953
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Diary

Keywords

Lower urinary tract symptoms; Quality of life

Outcome Measures

Primary Outcomes (1)

• Finish quality of life accessment

  Quality of life was accessed by King's Health Questionnaire

  January 2010 to December 2019

Study Arms (6)

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

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

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

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

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

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

Interventions

Bladder diary DIAGNOSTIC_TEST

A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.

Frequency; Nocturia; Normal; OAB-dry; OAB-wet; UI

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 19941278 RESULT

• 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.

  PMID: 19302497 RESULT

• 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.

  PMID: 29398096 RESULT

• 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.

  PMID: 25022469 RESULT

• 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.

  PMID: 25238744 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ho-Hsiung Lin, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)