Pelvic Floor Symptoms and Quality of Life in Elderly Wome... | NCT02338726

Studies
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study

NCT02338726

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Oct 21, 2016Estimated

Enrollment

143Actual

Phase

Not provided

Conditions

Urinary Incontinence
Quality of Life

Interventions

Gynecological examination

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jan 7, 2015

First Submission Date that Met QC Criteria

Jan 9, 2015

First Posted Date

Jan 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2016

Last Update Posted Date

Oct 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gynecological examination	Other	Comparison of questionnaires and gynecological examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validity of questionnaires to find pelvic floor symptoms		An average of 4 weeks, from returning the questionnaires to gynecological examination

Secondary Outcomes

Measure	Description	Time Frame
Quality of life in elderly women		◦Measures assessed at the time when questionnaires are filled in, one time point

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

64 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virpi Rantanen, MD	Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital		Turku		20520	Finland

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided