Clinical trial NCT02716506: FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: POP surgery
Lead sponsor: Society for Gynecological Surgery in Finland
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 3515
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 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.

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.

Eligibility 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

Primary outcomes:
measure: Quality of Life After the POP Surgery
timeFrame: 24 months after the surgery
Secondary outcomes:
measure: Symptoms Related to Pelvic Organ Prolapse
timeFrame: 24 months after the surgery
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: UEF
state: Eastern Finland
Study officials:
affiliation: Finnish Society of Gynecological Surgery
name: Päivi Härkki, PhD
role: STUDY_CHAIR
References: