Pelvic Organ Prolapse
Conditions
Keywords
POP surgery
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.
Interventions
PROCEDUREPOP surgery
Any surgical procedure that is done to treat the symptomatic POP
Sponsors
Society for Gynecological Surgery in Finland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life After the POP Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptoms Related to Pelvic Organ Prolapse | 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symptomatic POP Patients that were operated for POP in 2015 in Finland and participated the study | 3,512 |
| Total | 3,512 |
Baseline characteristics
| Characteristic | Symptomatic POP | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1748 Participants | — |
| Age, Categorical Between 18 and 65 years | 1764 Participants | — |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 10.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Finland | 3512 Participants | — |
| Sex: Female, Male Female | 3512 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,512 |
| other Total, other adverse events | 353 / 3,512 |
| serious Total, serious adverse events | 15 / 3,512 |
Outcome results
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.
Time frame: 24 months after the surgery
Population: Analysis of the patients who answered the 15-D questionnaire 24 months after the operation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Symptomatic POP | Quality of Life After the POP Surgery | 0.898 units on a scale |
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.
Time frame: 24 months after the surgery
Population: Change in PFDI-20 scores 24 months after the operation compared to the baseline scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic POP | Symptoms Related to Pelvic Organ Prolapse | 49.24 score on a scale | Standard Deviation 44.61 |