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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02716506
• Other study ID #: Finpop 2015
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: January 2025

Study information

• Verified date: June 2019
• Source: Society for Gynecological Surgery in Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3515
• Est. completion date: January 2025
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• POP surgery
Any surgical procedure that is done to treat the symptomatic POP

Locations

Country	Name	City	State
Finland	UEF	Kuopio	Eastern Finland

Sponsors (1)

Lead Sponsor	Collaborator
Society for Gynecological Surgery in Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life After the POP 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	Symptoms Related to Pelvic Organ Prolapse	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