Trial Outcomes & Findings for FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015 (NCT NCT02716506)

Results Overview

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.

Recruitment status

UNKNOWN

Target enrollment

3515 participants

Primary outcome timeframe

24 months after the surgery

Results posted on

2019-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Symptomatic POP POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP
Overall Study STARTED	3515
Overall Study 6 Months	2528
Overall Study 2 Years	2351
Overall Study COMPLETED	2351
Overall Study NOT COMPLETED	1164

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symptomatic POP n=3512 Participants Patients that were operated for POP in 2015 in Finland and participated the study
Age, Categorical <=18 years	0 Participants n=3512 Participants
Age, Categorical Between 18 and 65 years	1764 Participants n=3512 Participants
Age, Categorical >=65 years	1748 Participants n=3512 Participants
Age, Continuous	64.0 years STANDARD_DEVIATION 10.7 • n=3512 Participants
Sex: Female, Male Female	3512 Participants n=3512 Participants
Sex: Female, Male Male	0 Participants n=3512 Participants
Region of Enrollment Finland	3512 Participants n=3512 Participants

PRIMARY outcome

Timeframe: 24 months after the surgery

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

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.

Outcome measures

Outcome measures
Measure	Symptomatic POP n=2314 Participants POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP
Quality of Life After the POP Surgery	0.898 units on a scale Interval 0.894 to 0.902

SECONDARY outcome

Timeframe: 24 months after the surgery

Population: Change in PFDI-20 scores 24 months after the operation compared to the baseline scores.

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.

Outcome measures

Outcome measures
Measure	Symptomatic POP n=2342 Participants POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP
Symptoms Related to Pelvic Organ Prolapse	49.24 score on a scale Standard Deviation 44.61

Adverse Events

Symptomatic POP

Serious events: 15 serious events

Other events: 353 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Symptomatic POP n=3512 participants at risk POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP
Surgical and medical procedures Serious adverse event (Clavidien dindo IV)	0.43% 15/3512 • Number of events 15

Other adverse events

Other adverse events
Measure	Symptomatic POP n=3512 participants at risk POP surgery in year 2015 POP surgery: Any surgical procedure that is done to treat the symptomatic POP
Surgical and medical procedures Minor adverse events	10.1% 353/3512 • Number of events 353

Additional Information

Dr Nina Mattsson

Kanta-Häme Central Hospital

Phone: +358407338307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place