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Combination of Treatments With or Without Surgery in Localized Provoked Vulvodynia: Outcomes After Three Years of Follow-Up

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Combination of Treatments With or Without Surgery in Localized Provoked Vulvodynia: Outcomes After Three Years of Follow-Up

Author: Aalto, Anu P,Huhtala, Heini,Mäenpää, Johanna,Staff, Synnöve
Year: 2019
Source: https://trepo.tuni.fi/bitstream/10024/105577/1/combination_of_treatments_with_2019.pdf
ORIGINAL RESEARCH ARTICLE Open Access
Combina ion o T ea men s Wi h o Wi hou Su ge y
in Localized P o oked Vul odynia:
Ou comes A e Th ee Yea s o Follow-Up
Anu Pauliina Aal o,
1,2,
*Heini Huh ala,
3
Johanna Ma¨enpa¨a¨,
1,4
and Synno¨ e S a
1,4
Mos ul odynia pa ien s ecei e combina ions o se e al ea men modali ies o hei ch onic pain ul condi-
ion. I conse a i e ea men s ail, es ibulec omy is conside ed o be he ul ima e ea men op ion o local-
ized p o oked ul odynia (LPV). The aim o his desc ip i e s udy was o analyze elie o pain, quali y o li e (QoL),
and complica ions associa ed wi h combining su ge y wi h conse a i e ea men s among LPV pa ien s, bo h in
sho e m and a e 3 yea s o ollow-up.
The s udy popula ion consis ed o a e ospec i e pa ien coho o su gically (n=16) and only conse a i ely
(n=50) ea ed LPV pa ien s. QoL da a we e assessed by a alida ed ques ionnai e (RAND-36). Da a we e col-
lec ed by e iewing pa ien eco ds and by aid o pos al ques ionnai es. E ficacy o ea men s in elie o pain
was measu ed by nume ical a ing scale (NRS). Two mon hs a e su ge y, he NRS sco es assessed by a physician
we e lowe in he su ge y g oup han in pa ien s ea ed only conse a i ely ( p=0.008). Howe e , a e a median
o 36 mon hs o ollow-up, sel - epo ed NRS sco es and QoL showed no di e ence be ween he wo pa ien
coho s. Complica ion a e a e es ibulec omy was 18.8%. The findings sugges ha combining su ge y wi h
conse a i e ea men s may esul in a mo e e ec i e sho - e m educ ion o pain. Howe e , he e ec seemed
o be only empo a y, as no long- e m benefi was achie ed.
Keywo ds: quali y o li e; RAND-36; es ibulec omy; ul odynia; ul odynia ea men
In oduc ion
Vul odynia is a ch onic pain synd ome o unknown
e iology a ec ing 7–8% o women in popula ion-
based epidemiological s udies.
1,2
Vul odynia is usually
desc ibed as bu ning, s abbing, i ching, s inging, and
eeling o i i a ion. The 2015 Consensus and Te -
minology and Classifica ion o Pe sis en Vul a Pain
and Vul odynia
3
di ides ul a pain in o wo ca ego ies.
Thefi s ca ego yincludes ul a pain ha iscausedbya
specific clea ly iden ifiable diso de (e.g., pain caused by
geni al he pes). The second ca ego y includes ul a pain
ha is a leas 3 mon hs in du a ion and canno be clea ly
iden ified o linked o a specific cause. Howe e , i may
ha e po en ial associa ed ac o s. The desc ip o s o he
pain a e loca ion (local, gene alized, and mixed), ype
(p o oked, spon aneous, o mixed), onse (p ima y and
seconda y), and empo al pa e n (in e mi en , pe sis-
en , cons an , immedia e, and delayed). Symp oms can
o e lap and co-occu . Vul odynia may be associa ed
wi h a his o y o yeas in ec ion, ho monal ac o s, ge-
ne ic ac o s, pel ic floo dys unc ion, and psychological
ac o s.
3
The mos common clinical sub ype o ul a pain in
p emenopausal women is localized p o oked ul ody-
nia (LPV).
4
LPV is also conside ed o be he mos com-
mon o m o sexual pain in women <30 yea s o age.
5
1
Facul y o Medicine and Li e Sciences, Uni e si y o Tampe e, Tampe e, Finland.
2
Depa men o Obs e ics and Gynecology, Kan a-Ha
¨me Cen al Hospi al, Ha
¨meenlinna, Finland.
3
Facul y o Social Sciences, Uni e si y o Tampe e, Tampe e, Finland.
4
Depa men o Obs e ics and Gynecology, Tampe e Uni e si y Hospi al, Tampe e, Finland.
The abs ac o his s udy was p esen ed a he XXIV Wo ld Cong ess o ISSVD, A gen ina, in Sep embe 2017.
*Add ess co espondence o: Anu Pauliina Aal o, MD, Depa men o Obs e ics and Gynecology, Kan a-Ha
¨me Cen al Hospi al, Ah enis on ie 20, Ha
¨meenlinna 13530,
Finland, E-mail: anu.aal o@ho mail.com
ªAnu Pauliina Aal o e al. 2019; Published by Ma y Ann Liebe , Inc. This Open Access a icle is dis ibu ed unde he e ms o he C ea i e Commons
License (h p://c ea i ecommons.o g/licenses/by/4.0), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he
o iginal wo k is p ope ly ci ed.
BioResea ch Open Access
Volume 8.1, 2019
DOI: 10.1089/bio es.2018.0044
BioResea ch
OPEN ACCESS
25
Ch onic pain is known o ha e a nega i e impac on a
woman’s quali y o li e (QoL).
6,7
Di e en medical ea men modali ies o LPV con-
sis o local, opical, o o al medica ions. Pa ien s ea-
ed by a mul idisciplina y eam a e usually o e ed
physio he apy (including anscu aneous elec ical
ne e s imula ion), sexual counseling and he apy,
and psycho he apy. Al hough a mul idisciplina y ap-
p oach o LPV is ecommended,
8,9
i is ac ually no e -
idence based.
10
Su ge y ( es ibulec omy) o LPV is
ecommended as he ul ima e ea men op ion, i con-
se a i e ea men s ail o a e insu ficien in e ms o
pain educ ion.
Based on s udies conce ning su gical ea men o
LPV, epo ed success a es a y be ween 60% and
90%,
11
e en hough he compa ison o di e en s udies
is di ficul as he e m ‘‘success,’’ he su gical echnique
used and he leng h o ollow-up show conside able a -
ia ion.
11
The e is no defini i e consensus as o which
su gical echnique is he supe io one. In a e iew by
Tommola e al.,
12
which was based on 33 s udies on
su gical ea men o LPV (o ul a es ibuli is), i
was concluded ha he expe ience o indi idual su -
geons plays an impo an ole, and ha he aim o
su ge y should be o emo e all pain ul issues while
a oiding unnecessa y isks. The e iew also ound su -
ge y o be e ec i e and sa e.
12
Mos s udies on su gical ea men o LPV lack an-
domiza ion and/o con ols. One o he ew andom-
ized con olled s udies on es ibulec omy is ha by
Be ge on e al.,
13
which showed ha es ibulec omy
was mo e success ul han su ace elec omyog aphic
eedback and g oup cogni i e-beha io al he apy in
pain educ ion. As he au ho s s a ed, he e is a conce n
in in e p e ing hese esul s, due o a highe p e ea -
men d op-ou a e in he es ibulec omy g oup.
13
Howe e , he psychological and sexual unc ions
emained equally posi i e in all h ee g oups a e 6
mon hs o ollow-up. Ano he s udy ha included an-
domiza ion o he su gical (beha io al ea men and
su ge y) and nonsu gical (beha io al ea men only)
g oups, by Weijma Schul z e al.,
14
ound no di e ence
in he ou comes be ween hese wo ea men modali-
ies a e a mean o 2.5–3 yea s o ollow-up. In he e-
iew o Golds ein e al.,
11
su ge y was ecommended
o LPV a e ailu e o conse a i e ea men s (le el
B e idence).
In p e ious s udies conce ning su ge y o LPV, he
measu ed ou comes ha e a ied. A leas pain educ-
ion,
13,15
dyspa eunia,
13,16
sexual unc ioning,
13
psycho-
logical dis ess,
15
and pa ien sa is ac ion
16
ha e been
measu ed using ques ionnai es; mo eo e , findings o
physical examina ion and sel - epo ed symp oms ha e
also been epo ed. Psychological well-being,
17
quali y
o sexual li e,
17
and sexual and pa ne ship sa is ac ion
ha e all been epo ed o imp o e
18
a e es ibulec omy.
The aim o his s udy was o e alua e he sa e y and
e ec i eness o LPV ea men s wi h o wi hou su -
ge y in bo h sho and long e ms. Pain was measu ed
by nume ical a ing scale (NRS) assessed by bo h a
physician and he pa ien . QoL was e alua ed a e a
combina ion o ea men s wi h o wi hou su ge y,
using a ques ionnai e (RAND-36) alida ed in he
Finnish popula ion.
Ma e ials and Me hods
This e ospec i e coho s udy on LPV pa ien s was
ca ied ou a he Depa men o Obs e ics and Gyne-
cology o Tampe e Uni e si y Hospi al (TAUH),
Tampe e, Finland. All a leas 18-yea -old women diag-
nosed wi h ul odynia a TAUH om Janua y 2003 o
May 2016 we e sc eened o he s udy. Po en ial ul o-
dynia pa ien s we e iden ified om he hospi al eco ds
(compu e da abase) by using he app op ia e ICD-10
codes: N90.9 (noninflamma o y diso de o ul a and
pe ineum, unspecified); N90.8 (o he specified nonin-
flamma o y diso de s o ul a and pe ineum); N94.1
(dyspa eunia); and N94.2 ( aginismus). Only LPV pa-
ien s who ulfilled he s ic c i e ia by F ied ich,
19
o
se e e pain on es ibula ouch o a emp ed aginal
en y, and ende ness on localized p essu e wi hin he
ul a es ibule, we e conside ed eligible (n=66).
Among hese eligible pa ien s, 16 pa ien s ope a ed
on o LPV ( es ibulec omy) we e iden ified. Pa ien s
wi h gene alized o con inuous ul a pain we e ex-
cluded. O he exclusion c i e ia included malignan
umo s o ul a and ongoing inflamma o y o de ma-
ological diseases o ul a. The flow cha o s udy pa-
ien s is shown in Figu e 1.
In o ma ion on pa i y, menopausal s a us, age, di e -
en ea men modali ies, and complica ions a e su -
ge y was collec ed om he hospi al’s medical eco ds.
The baseline pain be o e any ea men s o LPV was
assessed by a physician wi h a co on swab es and
a ed on an NRS om 0 o 10. I he a ing was no
ound in he pa ien eco d, he in o ma ion was
epo ed as ‘‘no da a.’’ As a pa o he ea men p o o-
col, e e y pa ien had a checkup appoin men a 2
mon hs a e he su gical ea men wi h he ope a ing
su geon. Pa ien s ea ed wi h conse a i e me hods
Aal o, e al.; BioResea ch Open Access 2019, 8.1
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26
only we e assessed by a physician usually a e 2 o 3
mon hs a e commencing he ea men s. The conse -
a i e ea men modali ies used o LPV a e desc ibed
in Table 1.
The su gical echnique used was he modified pos e-
io es ibulec omy desc ibed by Tommola e al.,
16
wi h
he aim o su gically emo e he pain ul ul a a ea. The
ope a ions we e pe o med unde gene al anes hesia,
and all ope a ions we e ca ied ou by h ee senio gyne-
cological su geons. Fi s , 0.01% lidocain cum ad enalin
solu ion was injec ed in o he ul a es ibulum o
bleeding con ol and p e en ion o pos ope a i e pain.
To excise es ibula mucosa, 2-mm deep incisions
using elec ocau e y we e made om 10 o 2 o’clock
in he pos e io ul a es ibulum o a wid h o *1–
2 cm. The inne incision was made jus inside he hy-
menal ing, and he ou e ma gin ollowed he Ha ’s
line. The aginal mucosa was libe a ed om unde lying
issue and subsequen ly opposed o dis al ul a ma gin
wi h abso bable su u es wi hou ension.
A se en-page pos al ques ionnai e on demog aphic
da a, sel - epo ed pain, and RAND-36 was sen o
he 66 eligible LPV pa ien s. The ques ionnai e was e-
sen o he pa ien s who did no e u n he ques ion-
nai e wi hin 2 mon hs a e he fi s mailing.
The alida ed Finnish e sion o he RAND-36-i em
heal h su ey includes eigh mul i-i em dimensions:
gene al heal h, physical unc ioning, men al heal h, so-
cial unc ioning, i ali y, pain, and physical and emo-
ional ole unc ioning.
20,21
Pa icipan s o he s udy we e mo eo e asked o as-
sess ul a pain in ensi y upon ouch on he NRS be-
o e and a e ea men s. NRS was used o quan i y
he in ensi y o ul a pain by a ing he pain using a
0- o-10 scale, whe e 0 indica es ‘‘no pain’’ and 10 indi-
ca es ‘‘ he wo s pain imaginable.’’
The s udy p o ocol was app o ed by TAUH E hical
Commi ee (5APR2016, Iden ifica ion Code R16053),
and a w i en in o med consen was ob ained om
he pa ien s pa icipa ing in his s udy.
Ve sion 23 o IBM SPSS s a is ics so wa e was used
in s a is ical analyses (IBM SPSS S a is ics o Win-
dows, Ve sion 23.0. IBM Co p. 2015. A monk, NY).
Mann–Whi ney U- es was used o s a is ical compa -
isons. A p obabili y alue o p<0.05 was conside ed as
s a is ically significan .
Resul s
Thi y-six pa ien s (55%) e u ned he ques ionnai e
du ing he s udy pe iod (Augus 2016–No embe
2016). Twen y-eigh pa ien s e u ned he ques ionnai e
a e he fi s mailing and eigh pa ien s a e he second
mailing. The pa ien flow cha is shown in Figu e 1. The
esponse a e o pos al ques ionnai es in he nonsu gical
g oup was 46.0% and ha in he su gical g oup was
81.3% ( p=0.020). Demog aphic da a and pain be o e
and a e he ea men s a e shown in Table 1. A he
da a analysis poin 1 (2 mon hs a e commencing he
ea men s), he su gical and nonsu gical g oups di -
e ed significan ly in age ( p=0.048). The median
ollow-up ime a he da a analysis poin 2 was 36
mon hs (in e qua ile ange [IQR] =24–36). The mos
equen ( ecei ed by >50% o he pa ien s) combina ion
o conse a i e ea men s consis ed o local ea men s
(lidocaine and/o gabapen in), physio he apy, and sex-
ual counseling in bo h pa ien coho s. The ea men
modali ies used o bo h pa ien g oups a e summa ized
in Table 1. A he da a analysis poin 1, he nonsu gical
and su gical ea men g oups did no di e wi h espec
o any ea men modali y. Howe e , a he da a analysis
poin 2, he wo ea men g oups di e ed wi h espec
o he equency o sexual counseling (Table 1; p=0.03).
A da a analysis poin 1, median p e ea men NRS
sco es we e simila be ween nonsu gical (i.e., combina-
ion o ea men s wi hou su ge y) and su gical g oups
FIG. 1. Pa ien flow cha .
Aal o, e al.; BioResea ch Open Access 2019, 8.1
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27
(median NRS sco es 9 in bo h g oups, p=0.11, Table 1).
Median pos - ea men NRS sco e assessed by a physi-
cian in di e en ea men g oups was 7 and 2, espec-
i ely ( p=0.008). A e median o 36 mon hs o
ollow-up, sel - epo ed NRS sco es be o e o a e ea -
men s did no di e significan ly be ween he g oups
(p=0.66 and p=0.18, espec i ely, Table 1). A da a
analysis poin 2, we also compa ed medical eco d-
de i ed da a assessed by a physician. Physician-assessed
NRS sco e be o e ea men in he nonsu gical g oup
was 8 and ha in he su gical g oup was 9 ( p=0.014).
Simila ly, pos - ea men NRS sco e assessed by a physi-
cian was 7 and 2, espec i ely ( p=0.005). Among he
LPV pa ien s who did no espond o pos al ques ion-
nai es (n=30), he median p e ea men NRS sco e col-
lec ed om he pa ien eco ds was 9 (IQR=8–9.5,
missing da a n=13), and he median 2-mon h pos -
ea men NRS sco e was 5 (IQR =2.25–8, missing
da a n=14). When non esponde s we e compa ed
wi h all LPV pa ien s who e u ned he ques ionnai e
(da a analysis poin 2), he p e- and pos - ea men
NRS sco es de i ed om he medical eco ds we e sim-
ila ( p=0.291, p=0.592, espec i ely).
The QoL a e a median o 36 mon hs o ollow-up
a e ea men sdidno di e significan lybe ween he
su gical and nonsu gical g oups in any o he eigh
mul i-i em dimensions (Table 2 and Fig. 2).
Ou o 16 pa ien s ope a ed on, 3 had complica-
ions a e su ge y, esul ing in a complica ion a e o
18.8%. One pa ien had hea y pos ope a i e pain and
Table 1. Demog aphic Da a and T ea men s Gi en o Localized P o oked Vul odynia Pa ien s
Da a analysis poin 1 (Fig. 1).
Re iew o medical eco ds
Da a analysis poin 2 (Fig. 1).
Re iew o medical eco ds and pos al ques ionnai e
All LPV
pa ien s
Combina ion
o ea men s
wi hou su ge y
Combina ion
o ea men s
wi h su ge y p
a
All LPV
pa ien s
Combina ion
o ea men s
wi hou su ge y
Combina ion
o ea men s
wi h su ge y p
a
Numbe o pa ien s 66 50 16 N/A 36 23 13 N/A
Age, median (IQR) 28 (25–33) 27 (24–32.3) 30.5 (26.5–38.3) 0.048 28.5 (25–32) 27 (24–29) 29 (26.5–33) 0.06
Nullipa ous, % (n) 95.5 (63) 94 (47) 100 (16) 0.32 86 (31) 82.6 (19) 92.3 (12) 0.48
P emenopausal, % (n) 98.5 (65) 100 (50) 93.8 (15) 0.08 100 (36) 100 (23) 100 (13) 1.00
NRS be o e ea men s,
asked om pa ien s
a he ime o he
co on-swab es
9 (7.25–9),
n.d. n=22
9 (7–9),
n.d. n=18
9 (8–9.5),
n.d. n=4
0.11 9 (7–9),
n.d. =9
8 (7–9),
n.d. n=7
9 (8–10),
n.d. =2
0.014
NRS a e ea men s,
asked om pa ien s
a he ime o he
co on-swab es
5 (2–8),
n.d. n=24
7 (4–8),
n.d. n=19
2 (2–4),
n.d. n=5
0.008 5 (2–7),
n.d. n=10
7 (4.5–8),
n.d. =7
2 (2–4),
n.d. =3
0.005
Sel - epo ed NRS
be o e ea men s
in he pos al
ques ionnai e
N/A N/A N/A N/A 8 (8–9) 8 (7–9) 8 (8–9) 0.66
Sel - epo ed NRS
a e ollow-up
in he pos al
ques ionnai e
N/A N/A N/A N/A 3 (2–5.75) 4 (3–6) 2 (2–5) 0.18
T ea men s ecei ed by LPV pa ien s
Local ea men s,
b
%(n) 100 (66) 100 (50) 100 (16) 1.00 100 (36) 100 (23) 100.0 (13) 1.00
TCA o an icon ulsan
c
15.2 (10) 12.0 (6) 25.0 (4) 0.21 16.7 (6) 13.0 (3) 23.1 (3) 0.35
Physio he apy
(including TENS)
90.9 (60) 92.0 (46) 87.5 (14) 0.59 88.9 (32) 91.3 (21) 84.6 (11) 0.46
Sexual counseling
by a ained nu se
75.8 (50) 80.0 (40) 62.5 (10) 0.16 77.8 (28) 87.0 (20) 61.5 (8) 0.03
Topical ea men s
d
22.7 (15) 18.0 (9) 37.5 (6) 0.11 19.4 (7) 8.7 (2) 38.5 (5) 0.050
Local injec ions o
he pain ul si e
e
16.7 (11) 16.0 (8) 18.8 (3) 0.80 11.1 (4) 8.7 (2) 15.4 (2) 0.76
a
p- alue be ween su gical and nonsu gical g oups.
b
Lidocaine gel o he pain ul a ea in ul a 30 min be o e in e cou se o gabapen in 6% c eam applied wice a day o he pain ul a ea o 6–8 weeks.
c
Ami ip yline 10–40 mg mos commonly used TCA o p egabalin 150–300 mg.
d
Podophyllo oxin (5 mg/mL) applied locally o ende poin s o es ibulum a e 5% ace ic acid applica ion. T ea ed a ea was co e ed wi h a mild
es ogen c eam and co e ed wi h gauze pads un il he nex day.
e
2–4 mL o be ame asone and long ac ing anes he ic agen (bupi acaine), bo h 50% and 50%, injec ed submucuously o he pain ul si e.
IQR, in e qua ile ange; LPV, localized p o oked ul odynia; N/A, no applicable; n.d., no da a; NRS, nume ical a ing scale; TCA, icyclic an ide-
p essan ; TENS, anscu aneous elec ical ne e s imula ion.
Aal o, e al.; BioResea ch Open Access 2019, 8.1
h p://online.liebe pub.com/doi/10.1089/bio es.2018.0044
28
was eadmi ed o hospi al on he hi d pos ope a i e
day. Two mon hs a e su ge y, he pa ien was s ill su -
e ing om pain, whe eas a e 1 yea o ollow-up he
pain in he ul a a ea was ‘‘ ans o med in o a neu o-
pa hic pain,’’ and he pa ien was ea ed wi h pe o al
gabapen in, which esul ed in su ficien pain elie .
Ano he pa ien was eadmi ed a e 7 days o su ge y,
because o a pa ial wound dehiscence. The wound was
epo ed o ha e healed comple ely a he 2-mon h
ollow-up isi . The hi d pa ien su e ed om se e e
pain igh a e su ge y, and had o s ay o e nigh a
he hospi al. A 2-mon h ollow-up, he pain sco e was
assessed as ‘‘0’’ by he ope a ing physician.
Discussion
We desc ibe he e a e ospec i e coho o 66 LPV
pa ien s ea ed a ou ins i u ion. We e alua ed sho -
e m su gical complica ions, pain, and QoL o nonsu -
gically and su gically ea ed pa ien s fi s a e 2
mon hs and hen a e a median o 36 mon hs o
ollow-up. QoL a e 36 mon hs did no di e when
compa ing he su gically and only conse a i ely ea-
ed g oups in any o he eigh QoL dimensions o al-
ida ed RAND-36 ques ionnai e. Addi ion o su ge y o
he conse a i e ea men s esul ed in lowe NRS
sco es measu ed by a physician 2 mon hs a e su ge y.
Howe e , he e was no di e ence in sel - epo ed NRS
pain sco es measu ed a e he longe ollow-up.
Table 2. Quali y o Li e A e Follow-Up in Di e en
RAND-36 Dimensions
Combina ion
o ea men s
wi h su ge y
Combina ion
o ea men s
wi hou su ge y p
a
Physical unc ioning/
heal h, mean (SD)
95.4 (15.20) 92.4 (14.45) 0.243
Physical ole unc ioning,
mean (SD)
84.6 (33.13) 69.6 (43.92) 0.278
Emo ional ole unc ioning,
mean (SD)
66.7 (40.82) 56.5 (46.53) 0.498
Vi ali y, mean (SD) 58.1 (16.65) 51.5 (23.95) 0.518
Gene al men al heal h,
mean (SD)
68.9 (22.87) 65.7 (21.77) 0.416
Social unc ioning, mean (SD) 79.8 (19.46) 72.3 (27.94) 0.485
Pain, (SD) 75.2 (26.76) 64.7 (24.50) 0.144
Gene al heal h pe cep ions,
mean (SD)
63.9 (21.03) 62.2 (23.88) 0.974
a
p- alue be ween su gical and nonsu gical ea men g oups.
SD, s anda d de ia ion.
FIG. 2. Quali y o li e o LPV pa ien s measu ed wi h RAND-36. LPV, localized p o oked ul odynia.
Aal o, e al.; BioResea ch Open Access 2019, 8.1
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29

Ves ibulec omy seems o be a sa e ea men modali y
o LPV wi h an accep able complica ion a e. This is in
line wi h he p e ious e iew by Tommola e al. conce n-
ing su ge y o LPV.
12
In his s udy, su ge y was associ-
a ed wi h be e sho - e m ou comes in e ms o pain
a e 2 mon hs o su ge y. P e iously, i has been
shown ha medianpainmeasu edwi hVASdec eases
om 8 o 2 in su gically ea ed pa ien s,
18
which is o
a magni ude simila o ou esul s. Howe e , assessmen
o pain a he checkup isi s sho ly o a any ime poin
a e su ge y by he a ending su geon is no blinded and
ce ainly a isk o many ypes o bias. This bias may also
explain he di e ences shown he e be ween NRS alues
ob ained om medical eco ds and hose epo ed by pa-
ien s hemsel es. In a andomized s udy,
14
su gical in-
e en ion added o beha io al app oach had ou come
simila obeha io alapp oacha e 2.5–3yea so
ollow-up. A simila ou come was ound among pa ien s
gi en an oppo uni y o choose be ween su ge y and no
su ge y.Al hough hesamplesizein hes udywassmall
(n=14 in he andomized pa o he s udy), i being a
andomized s udy s eng hens he pe cep ion ha indi-
idual ailo ing o ea men is one o he key ac o s in
a success ul ea men o LPV.
We epo he e QoL da a ob ained wi h a alida ed
ques ionnai e among su gically and nonsu gically
ea ed ul odynia pa ien s. The e was no di e ence
in QoL be ween hese wo pa ien g oups a e a me-
dian o 3 yea s o ollow-up. P e iously, Bohm-S a ke
and Rylande ha e epo ed ha es ibulec omy im-
p o es QoL measu ed by VAS om median 0.5 o
6.5, du ing a median 41 mon hs o ollow-up.
17
How-
e e , ano he long- e m ollow-up s udy on LPV pa-
ien s ea ed conse a i ely e sus ea ed su gically
ailed o show any di e ence in long- e m well-
being be ween he ea men g oups.
18
E en i he e
a e p e ious aluable epo s on QoL and o e all
well-being among es ibulec omy pa ien s,
17,18
o
ou knowledge his is he fi s epo using a alida ed
QoL ques ionnai e when assessing QoL among es i-
bulec omy pa ien s.
The e a e some limi a ions o ou s udy. The s udy
is a e ospec i e non andomized c oss-sec ional
s udy. An ideal s udy se ing would ha e been a com-
pa ison be ween only su gically and nonsu gically
ea ed pa ien s p e e ably as a andomized con-
olled s udy. A con ounding ac o is ha he s udy
pa ien s in he su gical g oup had also ecei ed a i-
ous conse a i e ea men s be o e su ge y, ha is,
he compa ison be ween he g oups is in ac a com-
pa ison be ween combina ion o ea men s wi h and
wi hou su ge y. Because bo h g oups ecei ed a i-
ous conse a i e ea men modali ies i is no possi-
ble o conclude ully he e ec i eness o su ge y.
Howe e , his se ing is clinically una oidable since
es ibulec omy is he ea men modali y o e ed o
pa ien s only a e ailu e o all nonin asi e ea -
men s. The ac ha pa ien s we e asked o epo
pain e ospec i ely a e a median o 36 mon hs
a e ea men s con ains also a isk o bias. Howe e ,
he median ollow-up ime a e ea men s did no
di e significan ly be ween su gically and nonsu gi-
cally ea ed pa ien s ( p=0.35) and QoL measu ed
co esponded o p esen momen (i.e., he ime o
ques ionnai e). A longi udinal QoL e alua ion, done
be o e and a e ea men s, would ha e been o addi-
ional alue.
Al hough he o al numbe o pa ien s is ela i ely
low, wi h he su gically ea ed g oup being e en
smalle , i eflec s he ac ha ul odynia is a a he
a e condi ion. The esponse a e a e ollow-up was
only sa is ac o y, 55%. The esponse a e o pos al ques-
ionnai es o su gically ea ed pa ien s was highe and
his may lead o a alse accen ua ion o posi i e e ec
o he in e en ion, ha is, o a ype I e o . Howe e ,
pain a ed on he NRS and QoL did no di e signifi-
can ly be ween he g oups a e he longe ollow-
up. The amoun o missing da a was un o una ely
also qui e high and his may cause bias. The s udy pa-
ien s had ecei ed sligh ly di e en conse a i e ea -
men en i ies be o e su ge y o du ing he ea men
pe iod ha migh ha e an e ec on ou come, oo.
Conclusion
Measu ing QoL wi h a alida ed ques ionnai e in he
Finnish popula ion can be conside ed as s eng h o
he s udy. Bea ing in mind he limi a ions, as dis-
cussed ea lie , we conclude ha e en i su ge y
seems o be associa ed wi h mo e e ec i e pain man-
agemen in he sho e m, i showed no addi ional
benefi wi h espec o QoL o pain a e ex ended
ollow-up. In con as , i may be concluded ha pe -
o ming es ibulec omy a e conse a i e ea men s
is sa e and does no seem o be ha m ul. Howe e ,
long- e m pa ien - epo ed ou comes in e ms o
QoL and pain a e su ge y do no seem o di e
om hose achie ed conse a i ely. Conside ing e-
cen e idence o a s ong placebo e ec conce ning
medical ea men s,
22
p ospec i e su ficien ly pow-
e ed con olled ials a e uly wa an ed.
Aal o, e al.; BioResea ch Open Access 2019, 8.1
h p://online.liebe pub.com/doi/10.1089/bio es.2018.0044
30
Acknowledgmen
This s udy has ecei ed unding om he Compe i i e
S a e Resea ch Funding o he Expe Responsibili y
A ea o Tampe e Uni e si y Hospi al.
Au ho Disclosu e S a emen
The au ho s (A.P.A., J.M., and S.S.) epo conflic o
in e es s. Au ho s (H.H.) epo no conflic o in e es s.
A.P.A. has ecei ed a cong ess a el g an om Roche.
J.M. has ecei ed cong ess a el g an om As aZe-
neca and Roche and has wo ked as a consul an o
As aZeneca, Tesa o, Roche, MSD, and Clo is. S.S. has
ecei ed cong ess a el g an s om Roche, As a
Zeneca, and Tesa o.
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Abb e ia ions Used
IQR ¼in e qua ile ange
LPV ¼local p o oked ul odynia
N/A ¼no applicable
n.d. ¼no da a
NRS ¼nume ical a ing scale
QoL ¼quali y o li e
TAUH ¼Tampe e Uni e si y Hospi al
TCA ¼ icyclic an idep essan
TENS ¼ anscu aneous elec ical ne e s imula ion
VAS ¼ isual analogue scale
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