Pelvic Organ ProlapseNCT02716506

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

An observational study of Pelvic Organ Prolapse, run by Society for Gynecological Surgery in Finland at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 120 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: POP surgery
Type of treatment: Surgery or procedure
How many people: 3,515 participants
Where: 1 siteFinland
Study dates: Jan 2015to Jan 2025
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland

Who may be able to join

Symptomatic pelvic organ prolapse
Mental and psychological ability to understand the study information and to give an approval
Knowledge of Finnish or Swedish language

Who cannot join

Other than Finnish or Swedish language
Psychological disability to understand the study information

Trial locations and contacts

1 site in 1 country.

Finland1 site

UEF
Kuopio, Eastern Finland, 70100

Other trials in Finland

About this study

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

Read the 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.

Conditions: Pelvic Organ Prolapse
Being tested: POP surgery
Keywords: POP surgery
Medical subject headings: Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

POP surgeryProcedure or surgery
Any surgical procedure that is done to treat the symptomatic POP

Study groups in NCT02716506
Study group	Role	What they receive
Symptomatic POP		POP surgery in year 2015 Receives: Procedure: POP surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months after the surgery

Secondary outcomes (1)

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.
Measured: 24 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jan 2025

First posted23 Mar 2016 (estimated)
Study startJan 2015
Primary completionDec 2015
Study completionJan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,515 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02716506
Sponsor's protocol ID: Finpop 2015
Status last verified: Jun 2019
First submitted: 10 Nov 2015
Last updated: 26 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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. 2026 Jul;105(7):1384-1397. doi: 10.1111/aogs.70083. Epub 2025 Nov 24.
PubMed 41277806
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.
PubMed 39752612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02716506
Acronym / sponsor ID: Finpop 2015
Conditions: Pelvic Organ Prolapse
Keywords: POP surgery
Study type: Observational
Recruitment status: Unknown status
Enrolment: 3,515 participants (actual)
Lead sponsor: Society for Gynecological Surgery in FinlandUniversity, hospital or other
Study start: Jan 2015
Primary completion: Dec 2015 (actual)
Study completion: Jan 2025 (estimated)
First posted: 23 Mar 2016 (estimated)
Results: Posted 22 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
Symptomatic POP	–	Procedure: POP surgeryPOP surgery in year 2015

Who may qualify

Ages: 18 to 120 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland

Key inclusion criteria (3 listed)

Symptomatic pelvic organ prolapse
Mental and psychological ability to understand the study information and to give an approval
Knowledge of Finnish or Swedish language

Key exclusion criteria (2 listed)

Other than Finnish or Swedish language
Psychological disability to understand the study information

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
POP surgeryAny surgical procedure that is done to treat the symptomatic POP	Procedure or surgery	Symptomatic POP

Primary outcome

Quality of Life After the POP Surgery
Time frame: 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.

1 secondary outcome

Symptoms Related to Pelvic Organ Prolapse
Time frame: 24 months after the surgery

Results and safety

Results posted to the registry on 22 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symptomatic POP	3,515	2,351

Primary outcome: Quality of Life After the POP Surgery

Time frame: 24 months after the surgery. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Symptomatic POP n = 2314
Value	0.898 (0.894 to 0.902)

Population analysed: Analysis of the patients who answered the 15-D questionnaire 24 months after the operation.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symptomatic POP	15 of 3,512 (0.4%)	353 of 3,512 (10.1%)	0 of 3,512

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41277806Wihersaari 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. 2026 Jul;105(7):1384-1397. doi: 10.1111/aogs.70083. Epub 2025 Nov 24.
Derived from this study: PubMed 39752612Wihersaari 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.
Individual participant dataSharing planned: No

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Päivi Härkki, PhD study chair

Finnish Society of Gynecological Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse, run by Society for Gynecological Surgery in Finland at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life After the POP Surgery (time frame: 24 months after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716506, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.