Female LUTS and Quality of Life

NCT ID: NCT04547933

Last Updated: 2020-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2953 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Diary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Bladder diary

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 19941278 (View on PubMed)

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.

Reference Type RESULT
PMID: 19302497 (View on PubMed)

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.

Reference Type RESULT
PMID: 29398096 (View on PubMed)

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.

Reference Type RESULT
PMID: 25022469 (View on PubMed)

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.

Reference Type RESULT
PMID: 25238744 (View on PubMed)

Other Identifiers

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202006086RIND

Identifier Type: -

Identifier Source: org_study_id

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