Urinary IncontinenceNCT02338726
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
An observational study of Urinary Incontinence and Quality of Life, run by Turku University Hospital at 1 site in Finland.
Trial summary
To assess pelvic floor symptoms and quality of life in elderly women. Read more about this study
- Who is it for?
- Ages 64 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Quality of Life
- What is being tested?
- Gynecological examination
- How many people
- 143 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100-130 women aged 64-66 years in one single municipality
Who may be able to join
- All women in one municipality aged 64-66 years who are willing to participate in the study.
Who cannot join
- Persons under guardianship or who does not understand the used questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
To assess pelvic floor symptoms and quality of life in elderly women.
Read the 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.
- Conditions
- Urinary Incontinence, Quality of Life
- Being tested
- Gynecological examination
- Keywords
- urinary incontinence, pelvic floor, quality of life, elderly women
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecological examinationOther
Comparison of questionnaires and gynecological examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of questionnaires to find pelvic floor symptoms
Measured: An average of 4 weeks, from returning the questionnaires to gynecological examination
Secondary outcomes (1)
Quality of life in elderly women
Measured: ◦Measures assessed at the time when questionnaires are filled in, one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Virpi Rantanen, Turku University Hospital
- Investigators
- Virpi Rantanen, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338726
- Sponsor's protocol ID
- T268/2014
- Status last verified
- Oct 2016
- First submitted
- 7 Jan 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
- ClinicalTrials.gov ID
- NCT02338726
- Acronym / sponsor ID
- T268/2014
- Conditions
- Urinary Incontinence, Quality of Life
- Keywords
- urinary incontinence, pelvic floor, quality of life, elderly women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess pelvic floor symptoms and quality of life in elderly women.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 64 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100-130 women aged 64-66 years in one single municipality
Key inclusion criteria (1 listed)
- All women in one municipality aged 64-66 years who are willing to participate in the study.
Key exclusion criteria (1 listed)
- Persons under guardianship or who does not understand the used questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecological examinationComparison of questionnaires and gynecological examination | Other | – |
Primary outcome
Validity of questionnaires to find pelvic floor symptoms
Time frame: An average of 4 weeks, from returning the questionnaires to gynecological examination
1 secondary outcome
Quality of life in elderly women
Time frame: ◦Measures assessed at the time when questionnaires are filled in, one time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virpi Rantanen, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Quality of Life, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of questionnaires to find pelvic floor symptoms (time frame: An average of 4 weeks, from returning the questionnaires to gynecological examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.