Female LUTS and Quality of Life

Bladder Diary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547933
• Other study ID #: 202006086RIND
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2953
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Diary
• Lower Urinary Tract Symptoms

Intervention

Diagnostic Test:
• Bladder diary
A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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: — View Citation

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)/Internation — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finish quality of life accessment	Quality of life was accessed by King's Health Questionnaire	January 2010 to December 2019