FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015

June 13, 2019 updated by: Nina Mattsson, Society for Gynecological Surgery in Finland

Finnish Pelvic Organ Prolapse Surgery Survey 2015: Incidence, Methods, Complications and Effect on Quality of Life of Pelvic Organ Prolapse Operations in Finland in 2015

The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective and validated questionnaires are used to measure the symptoms of POP and the quality of life before and six months after the operation. Methods and complications of surgery are reported by doctors in all 40 participant hospitals.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients awaiting for surgical procedure for a symptomatic pelvic organ prolapse (POP) are recruited for the study. The recruiting is done in 41 hospitals in Finland, at gynecological outpatient clinics. Participants are given information of the study and give a written approval to join the study. Participants are asked to fill in questionnaires, that measure the quality of life. Three validated questionnaires are used: Pelvic Floor Distress Inventory PFDI-20, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire PISQ-12 and health-related quality of life instrument 15D. These questionnaires are sent to participants 6 months, 2 and 5 years after the surgical treatment. The participants are also asked to report adverse effects related to the treatment and their satisfaction to the treatment. Information about the surgical procedure (i.e. type and duration of the procedure, blood loss, antibiotic and thrombosis prophylaxis) by the operating doctors. Both immediate and delayed treatment-related adverse effects are also reported by the doctors. Data is partly collected by questionnaires filled in internet. All the collected data is protected by high security and coded before analyses. Permission of protocol used in this study is given by the Ethical Committee of University of Eastern Finland and Finnish National Institute for Health and Welfare.

Study Type

Observational

Enrollment (Actual)

3515

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

  • Finland
    • Eastern Finland
      • Kuopio, Eastern Finland, Finland, 70100
        • UEF

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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland

Description

Inclusion Criteria:

  • Symptomatic pelvic organ prolapse
  • Mental and psychological ability to understand the study information and to give an approval
  • Knowledge of Finnish or Swedish language

Exclusion Criteria:

  • Other than Finnish or Swedish language
  • Psychological disability to understand the study information

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic POP
POP surgery in year 2015
Procedure: POP surgery
Any surgical procedure that is done to treat the symptomatic POP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life After the POP Surgery
Time Frame: 24 months after the surgery
Quality of life is measured by using 15 dimensional quality of health measurement instrument. Minimum value is 0 and maximum value is 1. Higher scores mean better outcome.
24 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms Related to Pelvic Organ Prolapse
Time Frame: 24 months after the surgery
Condition-specific questionnaire Pelvic Floor Distress Inventory (PFDI-20) is used. Minimum value is 0 and maximum value is 300. Higher scores mean more bothersome symptoms.
24 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Society for Gynecological Surgery in Finland

Investigators

  • Study Chair: Päivi Härkki, PhD, Finnish Society of Gynecological Surgery

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

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Finpop 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Pelvic Organ Prolapse

Clinical Trials on POP surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe