- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02338726
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
October 20, 2016 updated by: Virpi Rantanen, Turku University Hospital
To assess pelvic floor symptoms and quality of life in elderly women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim is to assess pelvic floor symptoms and quality of life in elderly women.
The study is conducted as population-based in 100-130 women at the age of 64-66 years.
All study objects are examined gynecologically and with vaginal ultrasound.
Subjective symptoms are evaluated with validated questionnaires concerning pelvic floor symptoms, sexual symptoms and quality of life.
This is a pilot study before a larger scale population-based study.
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Turku, Finland, 20520
- Turku University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
64 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
100-130 women aged 64-66 years in one single municipality
Description
Inclusion Criteria:
- All women in one municipality aged 64-66 years who are willing to participate in the study.
Exclusion Criteria:
- Persons under guardianship or who does not understand the used questionnaires.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Validity of questionnaires to find pelvic floor symptoms
Time Frame: An average of 4 weeks, from returning the questionnaires to gynecological examination
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An average of 4 weeks, from returning the questionnaires to gynecological examination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life in elderly women
Time Frame: ◦Measures assessed at the time when questionnaires are filled in, one time point
|
◦Measures assessed at the time when questionnaires are filled in, one time point
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Virpi Rantanen, MD, Turku University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 9, 2015
First Posted (Estimate)
January 14, 2015
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 20, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T268/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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