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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic POP | POP surgery in year 2015 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POP surgery | Procedure | Any surgical procedure that is done to treat the symptomatic POP |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland
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| Name | Affiliation | Role |
|---|---|---|
| Päivi Härkki, PhD | Finnish Society of Gynecological Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UEF | Kuopio | Eastern Finland | 70100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41277806 | Derived | Wihersaari O, Karjalainen P, Tolppanen AM, Mattsson N, Jalkanen J, Nieminen K. Prolapse recurrence, methods of reoperation, and long-term mesh complications-A nationwide follow-up study. Acta Obstet Gynecol Scand. 2025 Nov 24. doi: 10.1111/aogs.70083. Online ahead of print. | |
| 39752612 | Derived | Wihersaari OAE, Karjalainen P, Tolppanen AM, Mattsson N, Nieminen K, Jalkanen J. Quality of Sexual Life Before and After Pelvic Organ Prolapse Surgery. Urogynecology (Phila). 2024 Oct 1;30(10):838-846. doi: 10.1097/SPV.0000000000001568. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptomatic POP | POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symptomatic POP | Patients that were operated for POP in 2015 in Finland and participated the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis of the patients who answered the 15-D questionnaire 24 months after the operation. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months after the surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symptomatic POP | POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event (Clavidien dindo IV) | Surgical and medical procedures | Systematic Assessment | Clavidien dindo classification |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor adverse events | Surgical and medical procedures | Calvidien dindo I-II | Systematic Assessment | Clavidien dindo I-III |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nina Mattsson | Kanta-Häme Central Hospital | +358407338307 | nina.mattsson@fimnet.fi |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Change in PFDI-20 scores 24 months after the operation compared to the baseline scores. | Posted | Mean | Standard Deviation | score on a scale | 24 months after the surgery |
|
|
|
| 0 |
| 3,512 |
| 15 |
| 3,512 |
| 353 |
| 3,512 |
|
|
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