Original Article
Gynecol Obstet Invest 2005;59:202–206
DOI: 10.1159/000084142
Treatment of Non-Atypic Endometrial
Hyperplasia Using Thermal Balloon
Endometrial Ablation Therapy
Ilkka Y. Järvelä Markku Santala
Department of Obstetrics and Gynaecology, Oulu University Hospital, Oulu, Finland
Key Words
Endometrial hyperplasia
Progestin, endometrial
hyperplasia
Thermal balloon endometrial ablation
therapy, endometrial hyperplasia
Abstract
Background/Aim: Traditionally endometrial hyperpla-
sias have been treated with progestins. Unfortunately,
quite often hyperplasias are resistant to treatment, or
they recur after therapy. The aim of the study was to
compare traditional progestin administration with ther-
mal balloon endometrial ablation in the treatment of
non-atypic endometrial hyperplasia. Methods: Women
with endometrial hyperplasia (n = 34) were randomized
in a 1: 1 allocation ratio. Endometrial biopsy samples
were taken 6 and 12 months after the treatment; if any
signs of hyperplasia were detected, hysterectomy was
performed. In addition, the hospital records were checked
in September 2003 to observe for any later hysterecto-
my. Main outcome measures were recovery from hyper-
plasia and avoidance of hysterectomy. Results: In pa-
tients treated with thermal ablation, the hyperplasias
persisted at 6 or 12 months in 4 out of 17 patients, where-
as the rate was 6 out of 17 patients in the progestin ther-
apy group. According to patient records, 1 further patient
© 2005 S. Karger AG, Basel
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Received: September 21, 2004
Accepted after revision: December 21, 2004
Published online: February 24, 2005
treated with thermal ablation and 3 further patients treat-
ed with progestin were hysterectomized after the last
visit. A total of 14 of the 34 patients (41%) have been hys-
terectomized so far. Conclusions: These preliminary re-
sults suggest that thermal balloon endometrial ablation
therapy seems to be as effective as traditional progestin
administration in the treatment of non-atypic endome-
trial hyperplasia. The hysterectomy rate during the fol-
low-up period was, however, considerably high, and,
therefore, hysterectomy might be considered even a
first-choice treatment for endometrial hyperplasias.
Copyright © 2005 S. Karger AG, Basel
Introduction
Endometrial hyperplasias are common gynaecological
disorders. They are classified as simple or complex ac-
cording to the extent of architectural abnormalities and
are further divided into two categories according to the
presence or absence of cytological atypia [1]. This classi-
fication predicts the likelihood of progression from hyper-
plasia to cancer [1]. Simple types progress to endometrial
cancer in 1% of the cases and complex types in 3% of them
[1].
Ilkka Y. Järvelä
Department of Obstetrics and Gynaecology
Oulu University Hospital, PL 5000
FIN–90014 Oulu (Finland)
Tel. +358 8 3152011, Fax +358 8 3154310, E-Mail ilkka.jarvela@oulu.fi
 Traditionally, endometrial hyperplasias have been
treated with progestins [2–4]. Unfortunately, the effec-
tiveness of the therapy is limited, and quite often the en-
dometrial hyperplasia is resistant to the treatment, or it
recurs after the therapy [2–5].
Thermal balloon endometrial ablation therapy has
been proved to be effective in treating severe menstrual
bleeding [6–8] and pain [6]. The heat during the treat-
ment induces a zone of coagulation in endometrium and
submucosal layers [9, 10] which finally, several months
after the treatment, results in contraction of the uterine
cavity subsequent to fibrosis [7, 11]. Because the clinical
efficacy of thermal balloon endometrial ablation therapy
lies in local destruction of endometrium and submucosal
layers [9–11], it might be effective in the treatment of en-
dometrial hyperplasias.
The aim of this preliminary study was to compare the
effects of traditional progestin administration with those
of thermal balloon endometrial ablation therapy in the
treatment non-atypic endometrial hyperplasias.
Patients and Methods
Between August 1997 and January 2002, women with simple
or complex endometrial hyperplasias (no atypical signs in the en-
dometrial biopsy sample) were enrolled in a randomized prospec-
tive trial in order to evaluate the clinical effectiveness of thermal
balloon endometrial ablation therapy in comparison with peroral
progestin administration. The Ethics Committee of the Medical
Faculty approved the study protocols, and all patients gave their
written informed consent.
Exclusion criteria were previous treatment with progestin (for
menorrhagia, simple or complex hyperplasia), atypical signs in en-
dometrial hyperplasia, pregnancy, desire for preservation of fertil-
ity, fibroids with a diameter 13 cm or fibroids distorting the uterine
cavity, abnormal uterine cavity as judged by transvaginal ultraso-
nography, suspected genital tract infection or malignancy, and pre-
vious endometrial ablation.
The patients were randomized to either thermal balloon treat-
ment or oral progestin administration in a 1:1 allocation ratio. Pre-
menopausal and postmenopausal patients were randomized sepa-
rately. In the progestin treatment group, premenopausal women
were treated with sequential medroxyprogesterone acetate at
10 mg/day during menstrual cycle days 15–24, for 3 months, and
postmenopausal women were treated with continuous medroxy-
progesterone acetate at 10 mg/day for 3 months.
The thermal balloon ablation was performed during cycle days
3–8 in premenopausal patients and on the day of randomization in
postmenopausal patients. The uterine thermal balloon system
(ThermaChoice®; Gynecare, Menlo Park, Calif., USA) used con-
sisted of a catheter (16 cm long, 4.5 mm in diameter) with a latex
end and a built-in heating element. The catheter was connected to
a control unit which monitored, displayed, and adjusted preset in-
tra-uterine balloon pressure, temperature, and duration of treat-
ment. The catheter was inserted transcervically to touch the uterine
Endometrial Thermo-Ablation for the
Treatment of Hyperplasias
fundus. No pretreatments with progestins, danazol, or gonadotro-
phin-releasing hormone agonists were used. The balloon was filled
with a variable volume of 5% dextrose in water, until the intra-uter-
ine pressure stabilized between 160 and 180 mm Hg. The fluid was
heated to 87 ° C, and the catheter was left in place for 8 min, after
which the balloon was emptied and the catheter removed. The op-
erations were performed under general anaesthesia and always by
the same experienced surgeon (M.S.).
Consecutive control visits, including clinical examination,
transvaginal ultrasonography, and endometrial biopsy, were sched-
uled 6 and 12 months after initiation of the therapy. In case any
sign of endometrial hyperplasia still existed, hysterectomy was con-
ducted. According to the normal clinical practice run in our unit,
if the ultrasonographic finding was abnormal and no endometrial
biopsy specimen could be obtained at the check-up visit, dilation
and curettage or hysterectomy was performed. In addition to this,
the patient records were checked in September 2003 to evaluate the
later need for medical interventions.
All statistical data were analyzed using the Statistical Package
for the Social Sciences (release 11.5.1; SPSS, Chicago, Ill., USA).
The
2 test was used for nominal data. Deviation from a normal
distribution was assessed using the Kolmogorov-Smirnov test.
Paired t tests were used for normally distributed data and the Wil-
coxon test for skewed data. p ! 0.05 was considered significant. All
values given are mean 8 SD.
Results
The study population consisted of 34 perimenopausal
women (mean age 48 years, age range 37–64 years), of
whom 17 were randomized to the thermal ablation group
and 17 to the progestin therapy group. No differences ex-
isted in mean age, number of deliveries, or in body mass
index between the groups (data not shown).
After treatment, the endometrial hyperplasia still per-
sisted in 4 out of the 17 patients in the thermal ablation
group, whereas the rate was 6 out of the 17 patients in the
progestin therapy group (table 1). All these 10 patients
were hysterectomized, but no hyperplasia was detected
in the final specimen. One postmenopausal patient in the
progestin therapy group had endometrial adenocarcino-
ma with tubal metastases (stage IIIa), and she had subse-
quently chemotherapy after hysterectomy.
According to the patient records, 1 patient treated with
thermal ablation and 3 patients treated with progestin
were hysterectomized after the last visit. The indications
for the operation were irregular bleeding and pain (fig. 1).
As a total, so far 5 out of the 17 patients in the thermal
ablation group and 9 out of the 17 patients in the proges-
tin treatment group have undergone hysterectomy.
Gynecol Obstet Invest 2005;59:202–206 203
Table 1. Individual patient information after the diagnosis of endometrial hyperplasia (n = 34)

Therapy Menopause Age Pretreatment Hyperplasias Time between Final diagnosis after
group years hyperplasia therapy and hysterectomy
after 6 months after 12 months
type hysterectomy, years

Thermal before 52 simple no no – –

ablation 49 no no – –
52 no no – –
49 no no – –
45 no no – –
46 no no – –
46 no no – –
44 no no – –
40 simple, focal – 0.71 atrophy
48 simple – 0.65 no abnormal findings
48 simple – 1.86 std proliferation
50 no simple, focal 1.36 atrophy
47 no no 1.49 std proliferationa
after 64 no no – –
57 no no – –
53 no no – –
51 no no – –

Progestin before 51 simple no no – –

51 no no – –
47 no no – –
43 no no – –
37 no no – –
45 no simple 1.13 std secretions
41 no simple 1.22 std secretions
42 no no 1.19 std proliferationa
45 no – 0.86 std proliferationa
50 no simple 1.36 std secretions
45 no simple 1.43 std proliferation
46 no no 5.03 atrophya
45 no simple 1.64 no abnormal findings
49 complex no no – –
after 52 simple no no – –
50 no no – –
55 complex, – 0.62 adenocarcinoma
atypical stage IIIa, grade 1

a
Hysterectomy was performed because the patients had pain/bleeding irregularities.

Discussion ablation therapy seems to offer a clinical option for the

This is a preliminary study which compared tradition-
al progestin administration to thermal balloon endome-
trial ablation therapy in the treatment of non-atypic endo-
metrial hyperplasias. According to our results, 76% of the
patients treated with thermal balloon endometrial abla-
tion therapy and 65% of those treated with progestin had
a normal endometrial biopsy specimen 6 or 12 months
after treatment. Therefore, thermal balloon endometrial
treatment of non-atypic endometrial hyperplasias.
Thermal balloon endometrial ablation therapy in-
duces locally a zone of coagulation in endometrium and
submucosal layers [9, 10]. The thermal coagulative effect
extends up to 7–8 mm [9, 10, 12]. Subsequent fibrosis
induces a gradual contraction of the uterine cavity [7, 11],
with a concomitant impairment of the uterine blood cir-
culation [13]. Theoretically, in the treatment of endome-
trial hyperplasia, these changes might end up into more

204 Gynecol Obstet Invest 2005;59:202–206 Järvelä/Santala


Fig. 1. Hysterectomized patients with respect to the hyperplasia
treatment. All indications (persistent hyperplasia after treatment,
bleeding irregularities, and pain) for hysterectomy included.
consistent results with lower recurrence rates than tem-
porary treatment with progestin.
The degree of fibrosis of the uterine cavity after ther-
mal balloon therapy seems to be related to the effect on
menorrhagia [7]. Friberg et al. [7] reported after thermal
balloon therapy that in 86% of the examinations they
could not pass a hysteroscope and that in 25% of the
cases they could not pass a saline infusion sonography
catheter (diameter 2 mm) through the inner cervical os.
Fibrosis resulted in haematometra in 4% of the patients
[7]. Despite the fact that in the present study no haema-
tometra was observed, the possibility of obstruction of
the uterine cavity after therapy is a true concern. In case
of posttherapeutic metrorrhagia and strictured inner cer-
vical os, the only option to exclude endometrial cancer is
hysterectomy. Therefore, the possibility of a later devel-
oping inaccessive uterine cavity [14] makes a limitation
of the use of thermal balloon endometrial ablation for any
indication, not only for endometrial hyperplasia.
During the follow-up period, 10 patients were oper-
ated due to persistence of endometrial hyperplasia in the
biopsy specimen. In 9 patients the sample suggested no
atypical signs, and in these patients the final pathological
investigation after hysterectomy revealed neither hyper-
plasia nor cancer. The accuracy of the endometrial bi-
Endometrial Thermo-Ablation for the
Treatment of Hyperplasias
opsy in relation to the final diagnosis after hysterectomy
was very low in our study; nevertheless, spontaneous re-
covery was also possible. The inaccuracy of endometrial
biopsy in diagnosing hyperplasia is well known [15]. A
recent review [15] showed that the likelihood of hyper-
plasia in the final specimen is lower than 60% after a
positive biopsy test, i.e., a biopsy specimen showing signs
of hyperplasia. On the other hand, the diagnostic accu-
racy seems to increase when atypical cells are present [15].
This was the case in our study too, since the patients with
atypical signs in the endometrial biopsy specimen had
endometrial adenomatous cancer in the final biopsy.
Of all our patients, 41% had undergone hysterectomy
so far; the rates in patients treated with thermal ablation
and progestin were 29 and 53%, respectively. It may be
that thermal ablation diminishes the need for hysterec-
tomy due to bleeding irregularities and pain in the long
term. In the treatment of menorrhagia, thermal ablation
has been found to be very effective in avoiding hysterec-
tomy, the hysterectomy rate being 15% during 1.5–5
years of follow-up after the operation [16, 17]. Another
question raised by the high hysterectomy rate in our study
is whether we should consider hysterectomy as a primary
treatment option which would abolish the need for re-
peated checkup visits and endometrial specimen sam-
pling.
A limitation of the present study was the low number
of patients. No statistically significant difference could be
observed between the two treatment groups. If the ob-
served recovery rates of 76 and 65%, respectively, were
true, the required patient number for each group to
achieve statistical significance would be 150. A number
of 300 patients to confirm the results would be practi-
cally possible in a multicentre study.
We have compared the clinical effectiveness of ther-
mal balloon endometrial ablation therapy to traditional
progestin therapy in the treatment of endometrial hyper-
plasia. According to our preliminary results, it seems that
thermal destruction of the endometrium is at least as ef-
fective as progestin therapy. In the present study, the hys-
terectomy rate during the follow-up period was, however,
considerably high. Therefore, hysterectomy might be
considered even a first-choice treatment which would
abolish the need for future checkup visits, interventions,
and the risk of endometrial cancer.
Acknowledgment
I.Y.J. was supported by the Finnish Medical Foundation.
Gynecol Obstet Invest 2005;59:202–206 205
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