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FINPOP 2012-2021

GKS 10.9.2021

Jyrki Jalkanen

Sidonnaisuudet Ei sidonnaisuuksia

2

FINPOP 2015 Tavoite: kerätä 1 vuoden ajalta kaikkien Suomessa

tehtävien gynekologisten laskeumaleikkausten tiedot

Arvioitu kokonaismäärä n. 4200 leikkausta

Pääasiallisesti seurattavat parametrit

Potilastyytyväisyys ja elämänlaatu leikkauksen jälkeen

Kirurgian tuloksellisuutta ennustavat tekijät

41/45 sairaalaa mukana

3

Tutkimusryhmä

Ohjaajat

Dos. Anna-Mari Heikkinen

Dos. Kari Nieminen

Dos. Jyrki Jalkanen

Prof. Anna-Maija Tolppanen

Tutkijat

LL Nina Mattsson

LL Päivi Karjalainen

LL Olga Wihersaari

Sairaala Nova4

Tutkimuskaavio

5

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2012• Idea of a study of safety and effectiveness of POP surgey in Kanta-Häme Central Hospital

2013

• Decision of a multicenter national cohort study organized by Finnish Society for GynecologicalSurgery

• Translation process of the prolapse-specific HRQoL questionnaires in Finnish

• Ethical and other study approvals

2014

• Pilot study• Recruirement and information of the doctors in all 45 Finnish hospitals performing POP surgery

2015• FINPOP 2015 study• 41 hospitals

• 3515 patients, 3535 operations for POP

2016• 6 months follow-up (n=2528)

2017

• 24 months follow-up (n=2351)• 1st Publication: Mattsson NK: Study I

2018• Data analysis (NM), HILMO-kysely komplikatioista (OW)

2019

• 3 Publications: Mattsson NK: Study II, Study III, Karjalainen PK: Study I

2020•Doctoral Thesis: Mattsson NK: The Effect of Pelvic Organ Prolapse Surgery on Quality of Lfe

•3 Publications: Mattsson NK Sudy IV, Karjalainen PK Study II, Wihersaari O, Study I

2021 5-v -kyselyn loppuun saattaminen

2133/2824 vastausta (75,5%)

Karjalainen PK, Study III

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FINPOP-julkaisut ad9/2021

Mattsson N, Nieminen K, Heikkinen AM, Jalkanen J, Koivurova S, Eloranta ML, Aaltonen R,

Tolppanen AM: Validation of short forms of the Pelvic Floor Distress Inventory (PFDI-20), Pelvic

Floor Impact Questionnaire (PFIQ-7) and Pelvic Organ Prolapse/Urinary Incontinence Sexual

Questionnaire (PISQ-12) in Finnish. Health and Quality of Life Outcomes 2017 15:88. Epub 2017

May 2.

Mattsson NK, Karjalainen P, Tolppanen AM, Heikkinen AM, Jalkanen J, Härkki P, Nieminen K:

Methods of surgery for pelvic organ prolapse in a nationwide cohort (FINPOP 2015). Acta Obstet

Gynecol Scand 2019;98:451-459.

Karjalainen PK, Mattsson NK, Nieminen K, Tolppanen A-M, Jalkanen JT: The relationship of

defecation symptoms and posterior vaginan wall prolapse in women undergoing pelvic organ

prolapse surgery. Am J Obstet Gynecol 2019;211:480.e1-10

Mattsson NK, Karjalainen P, Tolppanen A-M, Heikkinen A-M, Sintonen H, Härkki P, Nieminen K,

Jalkanen J: Pelvic organ prolapse surgery and quality of life – a nationwide cohort study. Am J

Obstet Gynecol 2020;222:588,e1-10.

Mattsson NK, Karjalainen P, Heikkinen A-M, Nieminen K, Jalkanen J, Tolppanen A-M: Agreement

between patient global impression scale of improvement, pelvic floor distress inventory and 15D in

measuring the outcome of pelvic organ prolapse surgery. Neurology and urodynamics 2020;1-8.

Karjalainen PK, Mattsson NK, Jalkanen JT, Nieminen K, Tolppanen A-M:Minimal Important

Difference and Patient Acceptable Symptom State for the Pelvic Floor Distress Inventory-20 among

patients undergoing pelvic organ prolapse surgery. I Urogynecol J. 2020, DOI: 10.1007/s00192-

020-04513-z

Wihersaari O, Karjalainen P, Tolppanen AM, Mattsson N, Jalkanen J, Nieminen K: Complications of

Pelvic Organ Prolapse Surgery in the 2015 Finnish Pelvic Organ Prolapse Surgery Survey Study.

Obstet Gynecol. 2020 Dec;136(6):1135-1144.

Karjalainen PK, Tolppanen AM, Mattsson NK, Wihersaari OAE, Jalkanen JT, Nieminen K: Pelvic

organ prolapse surgery and overactive bladder symptoms—a population-based cohort (FINPOP). I

Urogynecol J. 2021 https://doi.org/10.1007/s00192-021-04920-w

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https://doi.org/10.1007/s00192-020-04513-z

TULOKSET

Pahin oire

20.10.2017 16.54Gynekologisen Kirurgian Seura

Sivu 1 / 4ht tp:/ /gks.f i/

GKS Koulutuspäivät 28.-29.9.2017

Ohjelma ja LUENNOT

Koulutuspäivien ESITE

PRESYMPOSIUM 27.9.17

Perineaalinen ultraääni lantionpohjan ja laskeuman arvioinnissa

Presymposiumin OHJELMA

Dietz handout Pelvic Floor Ultrasound 2017

MERKITSE KALENTERIIN:

! Navigation

% o

f p

ati

en

ts

Tyytyväisyys leikkaustulokseen,pahimman oireen mukaan

1 = hyvin tyytyväinen

7 = hyvin tyytymätön




Ohjelma ja LUENNOT







! Navigation

PFDI-20 subscales

PFDI-

subscale

BASELINE SCORES,

Mean, median, SD,

(95%CI)

CHANGE of scores from

baseline to 6 Month

Mean, median, SD (95%CI)

Change of 6

Month mean

scores from

baseline , %

POPDI40.8, 37.5, 19.9, (40.0,

41.6)

- 29.6, 29.2, 20.7 (28.7,

30.4) - 73

UDI32.4, 29.2, 21.0 (31.5,

33.2)

- 15.4, 12.5, 19.7 (14.6,

16.1) - 45

CRADI26.3, 25.0, 19.6 (25.6,

27.1)

- 11.0, 9.4, 16.2 (10.3,

11.6) - 42

Best improvement of bulge symptoms

Least improvement in defecation problems




Ohjelma ja LUENNOT







! Navigation

15

Mattsson N et al. AJOG 2020




Ohjelma ja LUENNOT







! Navigation

15D-results, by question

Oireiden paraneminen,PGI-kysely

Mattsson N et al., AJOG 2020

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Outcomesatisfaction

Satisfied 87 %

Indifferent 5%

Dissatisfied 8%

REASONS FOR DISSATISFACTION:

Prolapse recurrenc

e33 %

No improvement of symptoms

12 %

De novosymptom…

Post op complication 8%

other 17%




Ohjelma ja LUENNOT







! Navigation

Mattsson N et al.AJOG 2020 and

Unpublished data

Would you recommend this operationto your friend if she had a similarproblem?

95%

5%

kylläYes

No

Mikä on muna ja mikä kana?

Karjalainen PK, Mattsson NK, Nieminen K, Tolppanen

A-M, Jalkanen JT: The relationship of defecation

symptoms and posterior vaginan wall prolapse in

women undergoing pelvic organ prolapse

surgery. Am J Obstet Gynecol 2019;211:480.e1-10

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FIGURE 2

Prevalence of bothersome symptoms by prolapse stage at baseline21

Improvement of bothersome bowel symptoms bysurgery, FINPOP-study

0

10

20

30

Baseline 6 months 24 months

Splinting Straining

Incomplete emptying FI, normal stool

FI, loose stool Flatal incontinence

Pain when defecating Urgency

Rectal prolapse

Karjalainen P, et. Al, AJOG 2019

Pe

rce

nta

ge

of

pa

tie

nts

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24

PROM-analyysit uudelle tasolle

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Neurourology and Urodynamics. 2020;39:2171–2178. wileyonlinelibrary.com/journal/nau | 2171

Received: 20 April 2020 | Accepted: 12 July 2020

DOI: 10.1002/nau.24467

O R I G I N A L C L I N I C A L A R T I C L E

Agreement between pat ient global impression scale of

improvement, pelvic floor distress inventory and 15D in

measur ing the outcome of pelvic organ prolapse surgery

Nina K. M attsson M D1,2 | Päivi Kar jalainen M D2,3 |

Anna M ar i Heikk inen PhD2,4 | Kar i Nieminen PhD5,6 | Jyrk i Jalkanen PhD7 |

Anna M ai ja Tolppanen PhD8

1Department of Obstetrics and

Gynecology, Kanta Häme Central

Hospital, Hämeenlinna, Finland

2Institute of Clinical Medicine, University

of Eastern Finland, Kuopio, Finland


Gynecology, Central Finland Central

Hospital, Jyväskylä, Finland

4Terveystalo, Finland


Gynecology, Tampere University Hospital,

Tampere, Finland

6Faculty of Medicine and Health

Technology, Tampere University,

Tampere, Finland

7Central Finland Hospital District,

Jyväskylä, Finland

8School of Pharmacy, University of

Eastern Finland, Kuopio, Finland

Correspondence

Nina K. Mattsson, MD, Department of

Obstetrics and Gynecology, Kanta Häme

Central Hospital, Hämeenlinna, Finland,

Rautatienkatu 66, 13220 Hämeenlinna,

Finland.

Email: [email protected]

Funding information

Emil Aaltosen Säätiö; Sosiaali ja

Terveysministeriö; Hämeen Rahasto

Abstract

Aims: To evaluate the correlation between three commonly used patient

reported outcome measures, two generic and one condition specific instru-

ment, in assessing the change in health related quality of life following pelvic

organ prolapse surgery.

M ethods: The generic health related quality of life measure 15 dimensional

instrument (15D), Patient Global Impression of Improvement (PGI I), and

prolapse specific Pelvic Floor Distress Inventory (PDFI 20) were used to assess

the effectiveness of pelvic organ prolapse surgery in the national FINPOP study

of 3535 surgeries (83% of all pelvic organ prolapse operations) performed in

Finland in 2015. Spearman correlations between PGI I, change in 15D and its

dimensions and change in PFDI 20 and its subscales over a 2 year follow up

were investigated. The proportion of concordant ratings was also studied by

investigating the proportion of women rated similarly (worse/no change/bet-

ter/much better) by two instruments according to validated cutoffs.

Resul ts: Among 2248 women for whom the 2 year change in all instruments

could be measured, changes in PFDI 20 and 15D and its dimensions were

weak (ρ< 0.2 for all except excretion; ρ= 0.39 and sexual activity; ρ= 0.27).

PFDI 20 change (ρ= 0.39) and its subscales (ρ= 0.19 0.40, all P< .001) were

more strongly correlated with PGI I. The proportion of fully concordant ratings

were higher for PFDI 20 and PGI I (50.6%) than for PFDI 20 and 15D (33.0%).

Conclusion: The weak correlations between 15D, PGI I, and PDFI 20 ob-

served in this study show that the quantified health gains are strongly de-

pendent on the chosen patient reported outcome measures. This demonstrates

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any

medium, provided the original work is properly cited and is not used for commercial purposes.

© 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC

MID ja arviointi-menetelmä

Karjalainen et al. IUJ 2020

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PASS ja PGI-I –vertailu

Karjalainen P et al. IUJ 2020

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PASS= patient acceptable symptom score

Karjalainen P et al. IUJ 2021

POP and OAB

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Komplikaatioista

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Original Research

Complications of Pelvic Organ ProlapseSurgery in the 2015 Finnish Pelvic OrganProlapse Surgery Survey Study

Olga Wihersaari, MD, Päivi Karjalainen, MD, Anna-Maija Tolppanen, PhD, Nina Mattsson, PhD,Jyrki Jalkanen, PhD, and Kari Nieminen, PhD

OBJECTIVE: To describe the major complicat ions of

pelvic organ prolapse (POP) surgery in Finland.

METHODS: The Finnish Pelvic Organ Prolapse Surgery

Survey 2015 study is a prospect ive cohort of POP

surgeries performed in Finland in 2015. Perioperat ive,

postoperat ive, and late complications during 1 year of

follow-up were compared among native tissue repair,

transvaginal mesh, and abdominal mesh surgery. Major

complications were assessed using the Clavien-Dindo

grading system. Predictive factors for major complica-

tions were studied with logistic regression analysis.

RESULTS: Within 1 year after POP surgery, 396 (11.2%)

of 3,515 women had at least one complication: 10.9%

after native tissue, 11.7% after transvaginal mesh, and

13.5% after abdominal mesh repair. The majority of

complications occurred within 2 months after surgery

and postoperat ive infection (4.3%) and bleeding or

hematoma (2.6%) were the most frequent. The incidence

of organ injuries was low. Mesh-augmented surgery was

associated with significantly higher rates of bladder and

bowel injuries than native tissue surgery. Complication-

related reoperat ions occurred significantly more often

after abdominal mesh repair than native tissue surgery

(5.2% vs1.8%, P5.001). Mesh-related complications were

diagnosed more often after transvaginal mesh repair. The

overall rate of major complications (Clavien-Dindo

grades III–V) was 3.3%. Abdominal mesh surgery was

associated with the highest rate of major adverse events

(8.8% vs native tissue repair 2.6% and transvaginal mesh

4.9%). The incidence of Clavien-Dindo grade IV or V

complications was rare (less than 0.6%). Mesh surgery

(transvaginal mesh adjusted odds ratio [aOR] 2.23, 95%

CI 1.31–3.80, and abdominal mesh aOR 3.02, 95% CI

1.67–5.46), longer operating time (aOR 2.84, 95% CI

1.78–4.53), prior POP surgery (aOR 1.68, 95% CI 1.00–

2.81) and difficult surgery (aOR 2.75, 95% CI 1.63–4.62)

were associated with an increased risk for occurrence of

major complications.

CONCLUSION: Serious adverse events were rare

regardless of the operative approach. However, mesh-

augmented surgery was associated with higher risk for


(Obstet Gynecol 2020;136:1135–44)

DOI: 10.1097/AOG.0000000000004159

Pelvic organ prolapse(POP) isacommon and often

asymptomatic condition, affecting up to 50% of

parouswomen when based on examination.1 The esti-

mated lifetime risk for prolapse surgery in the general

female population is between 12% and 18%.2–4 A

variety of surgical procedures have been designed to

reducePOP symptoms. There is, however, no consen-

sus on the optimal approach, which is reflected by

high reoperation ratesdue to recurrent prolapse, espe-

cially after native tissue repair.1,5,6 Even though POP

surgery isconsidered to be a relatively safe procedure,

serious adverse events do occur and especially mor-

bidity related to mesh procedures has raised concerns

worldwide.7

From the Department of Obstetrics and Gynecology, Tampere University

Hospital, and the Faculty of Medicine and Health Technology, Tampere

University, Tampere, the Institute of Clinical Medicine and the School of

Pharmacy, University of Eastern Finland, Kuopio, theDepartment of Obstetrics

and Gynecology, Central Finland Central Hospital, Jyväskylä, theDepartment of

Obstetrics and Gynecology, Kanta-Häme Central Hospital, Hämeenlinna, and

theCentral Finland Hospital District, Jyväskylä, Finland.

Financial support for thisstudy wasprovided by Finnish Society for Gynecolog-

ical Surgery (a nonprofit organization).

Each author has confirmed compliance with the journal ’s requirements for

authorship.

Corresponding author: Olga Wihersaari, MD, Department of Obstetrics and

Gynecology, Tampere University Hospital, Tampere, Finland; email:

[email protected].

Financial Disclosure

Theauthorsdid not report any potential conflicts of interest.

© 2020 by theAmerican College of Obstetriciansand Gynecologists. Published

by WoltersKluwer Health, Inc. All rights reserved.

ISSN: 0029-7844/20

© 2020 by the American College of Obstetriciansand Gynecologists. Published by Wolters Kluwer Health, Inc.

Unauthorized reproduction of this article is prohibited.

VOL. 136, NO. 6, DECEMBER 2020 OBSTETRICS & GYNECOLOGY 1135

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Original Research

Complications of Pelvic Organ ProlapseSurgery in the 2015 Finnish Pelvic OrganProlapse Surgery Survey Study

Olga Wihersaari, MD, Päivi Karjalainen, MD, Anna-Maija Tolppanen, PhD, Nina Mattsson, PhD,Jyrki Jalkanen, PhD, and Kari Nieminen, PhD

OBJECTIVE: To describe the major complicat ions of

pelvic organ prolapse (POP) surgery in Finland.

METHODS: The Finnish Pelvic Organ Prolapse Surgery

Survey 2015 study is a prospect ive cohort of POP

surgeries performed in Finland in 2015. Perioperat ive,

postoperat ive, and late complications during 1 year of

follow-up were compared among native tissue repair,

transvaginal mesh, and abdominal mesh surgery. Major

complications were assessed using the Clavien-Dindo

grading system. Predict ive factors for major complica-

tions were studied with logistic regression analysis.

RESULTS: Within 1 year after POP surgery, 396 (11.2%)

of 3,515 women had at least one complication: 10.9%

after native tissue, 11.7% after transvaginal mesh, and

13.5% after abdominal mesh repair. The majority of

complications occurred within 2 months after surgery

and postoperat ive infection (4.3%) and bleeding or

hematoma (2.6%) were the most frequent. The incidence

of organ injuries was low. Mesh-augmented surgery was

associated with significantly higher rates of bladder and

bowel injuries than native tissue surgery. Complication-

related reoperat ions occurred significantly more often

after abdominal mesh repair than native tissue surgery

(5.2% vs 1.8%, P5 .001). Mesh-related complications were

diagnosed more often after transvaginal mesh repair. The

overall rate of major complications (Clavien-Dindo

grades III–V) was 3.3%. Abdominal mesh surgery was

associated with the highest rate of major adverse events

(8.8% vs native tissue repair 2.6% and transvaginal mesh

4.9%). The incidence of Clavien-Dindo grade IV or V

complications was rare (less than 0.6%). Mesh surgery

(transvaginal mesh adjusted odds ratio [aOR] 2.23, 95%

CI 1.31–3.80, and abdominal mesh aOR 3.02, 95% CI

1.67–5.46), longer operat ing time (aOR 2.84, 95% CI

1.78–4.53), prior POP surgery (aOR 1.68, 95% CI 1.00–

2.81) and difficult surgery (aOR 2.75, 95% CI 1.63–4.62)

were associated with an increased risk for occurrence of


CONCLUSION: Serious adverse events were rare

regardless of the operat ive approach. However, mesh-

augmented surgery was associated with higher risk for


(Obstet Gynecol 2020;136:1135–44)

DOI: 10.1097/AOG.0000000000004159

Pelvic organ prolapse (POP) isa common and often

asymptomatic condition, affecting up to 50% of

parouswomen when based on examination.1 The esti-

mated lifetime risk for prolapse surgery in the general

female population is between 12% and 18%.2–4 A

variety of surgical procedures have been designed to

reduce POP symptoms. There is, however, no consen-

sus on the optimal approach, which is reflected by

high reoperation rates due to recurrent prolapse, espe-

cially after native tissue repair.1,5,6 Even though POP

surgery isconsidered to be a relatively safe procedure,

serious adverse events do occur and especially mor-

bidity related to mesh procedures has raised concerns

worldwide.7

From the Department of Obstetrics and Gynecology, Tampere University

Hospital, and the Faculty of Medicine and Health Technology, Tampere

University, Tampere, the Institute of Clinical Medicine and the School of

Pharmacy, University of Eastern Finland, Kuopio, theDepartment of Obstetrics

and Gynecology, Central Finland Central Hospital, Jyväskylä, theDepartment of

Obstetrics and Gynecology, Kanta-Häme Central Hospital, Hämeenlinna, and

the Central Finland Hospital District, Jyväskylä, Finland.

Financial support for this study wasprovided by Finnish Society for Gynecolog-

ical Surgery (a nonprofit organization) .

Each author has confirmed compliance with the journal ’s requirements for

authorship.

Corresponding author: Olga Wihersaari, MD, Department of Obstetrics and

Gynecology, Tampere University Hospital, Tampere, Finland; email:

[email protected].

Financial Disclosure

Theauthors did not report any potential conflicts of interest.

© 2020 by the American College of Obstetricians and Gynecologists. Published

by Wolters Kluwer Health, Inc. All rights reserved.

ISSN: 0029-7844/20

© 2020 by the American College of Obstetriciansand Gynecologists. Published by Wolters Kluwer Health, Inc.

Unauthorized reproduction of this article is prohibited.

VOL. 136, NO. 6, DECEMBER 2020 OBSTETRICS & GYNECOLOGY 1135

Komplikaatiota (1 vuoden seuranta):

NT: 10,9%

TVM: 11,7%

AM: 13,5% Yhteensä 11,2%

Vakaville komplikaatioille (3,3%) (Clavien Dindo III-IV) tekijät altistavat:

TVM: OR 2,23

AM: OR 3,02

Pitkä leikkausaika: OR 2,84

Aiempi laskeumaleikkaus: OR 1,68

Vaikea leikkaus: OR 2,75

Mitä tämä lysti on maksanut?

GKS vv. 2013-2021

N. 43t€

luvat, lomakkeet, postitukset, rekisterikyselyt

Nina Mattsson

Henkilökohtaisia apurahoja n. xx t€

Päivi Karjalainen

Henkilökohtaisia apurahoja (ml. VTR) n. xxt€

Olga Wihersaari

Henkilökohtaisia apurahoja (ml. VTR ) n. xxt€

Tutkimusryhmällä kuluapurahaa (SKR) xx t€

30

Tulevaisuus 5-v –seurantadatan analyysi

Laskeumakirurgian vaikutus seksuaaliterveyteen

Uusintaleikkauksiin joutuvat potilaat

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Tutkimuksen”low points”

32

Opetus: muista varmuuskopiointi!

ESGE,Belek 2017

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…and ups!

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