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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716506
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Results First Posted : February 22, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Mattsson, Society for Gynecological Surgery in Finland

Brief Summary:
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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: POP surgery

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3515 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716506


Locations
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Finland
UEF
Kuopio, Eastern Finland, Finland, 70100
Sponsors and Collaborators
Society for Gynecological Surgery in Finland
Investigators
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Study Chair: Päivi Härkki, PhD Finnish Society of Gynecological Surgery
Additional Information:

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Responsible Party: Nina Mattsson, MD, Society for Gynecological Surgery in Finland
ClinicalTrials.gov Identifier: NCT02716506    
Other Study ID Numbers: Finpop 2015
First Posted: March 23, 2016    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nina Mattsson, Society for Gynecological Surgery in Finland:
POP surgery
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical