NCT01891162

Brief Summary

Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk factors for female urinary incontinence and pelvic organ prolapse at the population level. The socioeconomic risks for incontinence have however, conflicting evidence with assorted measures of socioeconomic status. Brazil is a country with enormous social contrasts, and deep inequality. We have a mixed origin of cultures and different economic and regional conditions. We believe that the perception and the impact that has Pelvic floor dysfunction in the quality of life of the woman must vary widely according to socioeconomic status (including household income, highest educational level, family income). There is to date no studies have correlated a criterion for classifying economic official in Brazil with the impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and pelvic organ prolapse.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

March 8, 2013

Last Update Submit

August 30, 2013

Conditions

Keywords

quality of life, incontinence urinary, socioeconomic

Outcome Measures

Primary Outcomes (1)

  • Assessment of socioeconomic status by Brazil and quality of life for urinary in Brazilian women

    one year

Study Arms (2)

Control

Assessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT

Study

Will be held evaluate the quality of life for general and specific pelvic floor dysfunction beyond the functional assessment of the pelvic floor through the PERFECT.

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

will be avalueted women who will be postmenopausal, who are not taking hormone therapy in the last six months. Women with urinary loss, which does not have non-inhibited contraction of the detrusor proven by urodynamic study. Will be compared with a group of women without pelvic floor dysfunction confirmed by clinical history and gynecological examination with the same characteristics in relation to postmenopausal status, all from the general gynecology outpatient clinic.

You may qualify if:

  • postmenopausal women
  • clinical diagnosis of urinary incontinence and / or pelvic organ prolapse
  • without contraction uninhibited detrusor

You may not qualify if:

  • cognitive deficit
  • presence of uninhibited detrusor contraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cesar cals hospital

Fortaleza, Ceará, 60125120, Brazil

Location

General Hospital Fortaleza

Fortaleza, Ceará, 60125120, Brazil

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • ISABELLA P FROTA

    Pesquisadora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2013

First Posted

July 2, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations