NCT02716506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,515

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 22, 2019

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

November 10, 2015

Results QC Date

October 17, 2018

Last Update Submit

June 13, 2019

Conditions

Keywords

POP surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Symptoms Related to Pelvic Organ Prolapse

    24 months after the surgery

Study Arms (1)

Symptomatic POP

POP surgery in year 2015

Procedure: POP surgery

Interventions

POP surgeryPROCEDURE

Any surgical procedure that is done to treat the symptomatic POP

Symptomatic POP

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UEF

Kuopio, Eastern Finland, 70100, Finland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Nina Mattsson
Organization
Kanta-Häme Central Hospital

Study Officials

  • Päivi Härkki, PhD

    Finnish Society of Gynecological Surgery

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 10, 2015

First Posted

March 23, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2025

Last Updated

June 26, 2019

Results First Posted

February 22, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations