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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Finhyst 2006: Study on Morbidity of Hysterectomies in Finland

NCT00744172

Morbidity of Hysterectomy

COMPLETED NA

Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

NCT06902909

Vaginal Vault Prolapse Uterine Prolapse Cystocele, Midline +1 more

ENROLLING_BY_INVITATION

Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

NCT04890951

Pelvic Organ Prolapse

UNKNOWN

Follow-up Study After Manchester Operation for Pelvic Organ Prolapse

NCT02246387

Pelvic Organ Prolapse

COMPLETED

Evaluation of Sexual Function and Quality of Life Tests in Patients Who Underwent Manchester Operation for Pelvic Organ Prolapse

NCT06975956

Pelvic Organ Prolapse (POP)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Symptomatic POP

POP surgery in year 2015

POP surgery

Intervention Type PROCEDURE

Any surgical procedure that is done to treat the symptomatic POP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POP surgery

Any surgical procedure that is done to treat the symptomatic POP

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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