NCT00765622

Brief Summary

The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
Last Updated

October 3, 2008

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

October 2, 2008

Last Update Submit

October 2, 2008

Conditions

Urinary Incontinence

Keywords

Urinary incontinencepelvic floorfunctional evaluation

Outcome Measures

Primary Outcomes (1)

  • All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure

    Only one measure at the begging of the study

Study Arms (2)

G2

G2 = control group (no incontinence)

G1

G1 = urinary incontinence

Eligibility Criteria

Age58 Years - 87 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

elderly women

You may qualify if:

  • Elderly women
  • Urinary incontinence

You may not qualify if:

  • Cesarean surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC

Brasília, Federal District, 71966-700, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Women

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia EC Souza, Ms

    Catholic University of brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

October 3, 2008

Record last verified: 2008-08

Locations

BR(1)