NCT02338726

Brief Summary

To assess pelvic floor symptoms and quality of life in elderly women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

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

First Submitted

Initial submission to the registry

January 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

January 7, 2015

Last Update Submit

October 20, 2016

Conditions

Urinary IncontinenceQuality of Life

Keywords

urinary incontinencepelvic floorquality of lifeelderly women

Outcome Measures

Primary Outcomes (1)

  • Validity of questionnaires to find pelvic floor symptoms

    An average of 4 weeks, from returning the questionnaires to gynecological examination

Secondary Outcomes (1)

  • Quality of life in elderly women

    ◦Measures assessed at the time when questionnaires are filled in, one time point

Interventions

Gynecological examinationOTHER

Comparison of questionnaires and gynecological examination

Eligibility Criteria

Age64 Years - 66 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100-130 women aged 64-66 years in one single municipality

You may qualify if:

  • All women in one municipality aged 64-66 years who are willing to participate in the study.

You may not qualify if:

  • Persons under guardianship or who does not understand the used questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

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

  • Virpi Rantanen, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 14, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

FI(1)