Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Female LUTS and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547933
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment
Bladder Diary 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2953 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Analysis of Quality of Life With Different Groups of Female Lower Urinary Tract Symptoms Based on Bladder Diary
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Finish quality of life accessment [ Time Frame: January 2010 to December 2019 ]
    Quality of life was accessed by King's Health Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with lower urinary tract symptoms completed a 3-day bladder diary and King's Health Questionnaire.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547933


Locations
Layout table for location information
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital
Publications of Results:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04547933    
Other Study ID Numbers: 202006086RIND
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared under reasonable request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Lower urinary tract symptoms
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Lower Urinary Tract Symptoms
Urological Manifestations