FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 3200
Summary
- Conditions
- Pelvic Organ Prolapse
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 120 years
- Gender
- Only males
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. P...
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.
Tracking Information
- NCT #
- NCT02716506
- Collaborators
- Not Provided
- Investigators
- Study Chair: Päivi Härkki, PhD Finnish Society of Gynecological Surgery