Köchli OR (ed): Hysteroscopy. State of the Art.

Contrib Gynecol Obstet. Basel, Karger, 2000, vol 20, pp 154–160

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Hydrothermal Ablation
A New Simple Method for Coagulating Endometrium in Patients with
Therapy-Resistant Recurring Hypermenorrhea

Thomas Römer, Jörg Müller, Dolores Foth

Department of Obstetrics and Gynaecology, University Hospital,
University of Cologne, Germany

Abstract
Hydrothermablation is a new method which could replace the electrosurgical
method of endometrial ablation. Some prospective studies were carried out to
assess efficacy, safety and tolerability of hydrothermablation in the treatment of
recurrent menorrhagias. Hydrothermablation is an intervention with coagulation at
the endometrium: temperature 90 ° C and duration 10 min with simultaneous hyste-
roscopic control. In a follow-up of least 12 months, about 35% of the patients had an
amenorrhea and the treatment was successful (reduction of pathological blood flow)
in about 87% of the patients. Complications were vaginal burns in 2 cases. No other
intra- or postoperative complications occurred. Hydrothermablation is a safe and
effective method for treatment of recurrent menorrhagias. This method offers a sim-
ple possibility to perform endometrial ablation without extensive training of the sur-
geon and can contribute to avoid hysterectomy.

Endometrial ablation has increasingly gained acceptance in recent years as

an alternative for hysterectomy for treatment of therapy-resistant bleeding disor-
ders [1–4]. The methods currently used are YAG laser or roller-ball ablation, as
well as transcervical resection of the endometrium. Problems exist with these
methods with regard to learning the demanding surgical technique, the high costs
of procuring the instrumentation and last, but not least, the admittedly few, but
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frequently serious complications arising from such interventions [4, 5]. This dis-
suades most gynecologists from carrying out this operation, so that, at present, a
large proportion of patients undergo a traditional hysterectomy.
By simplifying the technique, it is conceivable that this method would also
find more liberal use. The first clinical results of a pilot study with the Hydro
ThermAblator® (BEI Medical Systems, Hackensack, N.J., USA), devised by Gol-
drath et al. [6] will be introduced.

Study 1 (Pilot Study) [7]

Patients and Methods

18 patients who underwent endometrial ablation because of recurring, therapy-resis-
tant hypermenorrhea were selected according to the following exclusion criteria: glandular
cystic and adenomatous hyperplasia, large uterine myomata, carcinoma, submucous myo-
mata and polyps as well as structural abnormalities of the uterus. The age of the 18 patients
averaged 41 B 5 years. A hysteroscopy was performed on all patients either on an in-patient
or out-patient basis and the diagnosis was confirmed histologically by curettage or biopsy.
After the inclusion criteria were checked, pretreatment was carried out with 2 injections of
GnRH analog at an interval of 4 weeks (3.75 g of leuprorelin acetate depot, Enantone Gyn®,
Takeda Pharma, Aachen, Germany). Two weeks after the last injection, a preoperative vagi-
nal sonogram was taken, which showed that on average, the thickness of the endometrium
was 2.1 B 0.5 mm (i.e. one half the normal thickness). Hydrothermal ablation was then
carried out.
For the hydrothermal ablation, a saline solution, heated to 90 ° C, was instilled through
a continuous flow, insulated, hysteroscopic sheath inserted into the uterus (fig. 1). The pro-
gress of the coagulation of the endometrium is observed through a 2.9-mm optical system
(Karl-Storz GmbH, Tuttlingen, Germany) installed within the insulated sheath. Due to the
low intrauterine pressure, which is produced by only hydrostatic effect, no flow through the
tubes can be detected at 50 mm Hg [6]. A dilation of the cervix up to Hegar 8 is necessary in
order to introduce the sheath which measures 7.8 mm in diameter (fig. 2). The cervix must
be sealed tightly in order to prevent leakage which shuts off the flow of fluid after 10 cm3 is
lost. After a diagnostic evaluation of the uterine cavity, during which the saline solution is at
body temperature, the heating of the saline solution is commenced. The 10-min coagulation
of the endometrium takes place at 90 ° C. After that, the hot saline solution is automatically
replaced with room temperature saline, cooling the system to body temperature. The hyste-
roscope and sheath can then be safely removed. During the coagulation process, the changes
in the endometrium can be observed clearly through the optical system (fig. 3–5). A well
coagulated endometrium is obtained, even in the region of the cornua. All patients received
a clinical and sonographic check-up after 1, 6 and 12 months.

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 Fig. 1. Hydrothermal ablation
equipment – Hydro Therm-
Ablator® control unit (Hackensack,
BEI Medical Systems, N.J., USA).

Fig. 2. Insulated sheath for in-

stilling saline solution for hydro-
thermal ablation, which prevents
transfer of 90 ° C effect to the cer-
vix, with a 2.9-mm Hysteroscope.

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3 4

Fig. 3. Hysteroscopic picture 1: Initial

state of the endometrium in the tubal cor-
nua. Pretreatment with 2 injections of
GnRH analogs.
Fig. 4. Hysteroscopic picture 2: Condi-
tion of the endometrium in the tubal cornua
after 5 min of treatment.
Fig. 5. Hysteroscopic picture 3: Com-
pletely coagulated endometrium in the tubal
cornua at the end of the hydrothermal abla-
tion (after 10 min of treatment). 5

Results

All patients, who were followed up for at least 12 months, were evaluated.
For the 18 patients, amenorrhea was thus attained in 9 cases and hypomenorrhea
in 7 cases and eumenorrhea in 1 case. In 1 patient a vaginal hysterectomy was
carried because she suffered from recurrent dysmenorrhea. The uterus specimens
showed an adenomyosis. Up to the present, 17 patients are satisfied with the
result of the intervention. It was possible to obtain a reduction in dysmenorrhea
in 8 of 9 patients. Up to now, only 1 second intervention was necessary. There
were no intra- or postoperative complications.

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 Study 2 (German Multicenter Trial)

The German Multicenter Trial was performed in 4 endoscopic centers

(Greifswald, Oldenburg, Chemnitz, Rottweil). Results of the pilot study of HTA
should be proved. After outpatient hysteroscopy with biopsy, all patients was pre-
treated with 2 injections of GnRH analogues and then 2 weeks after the second
injection the hydrothermablation was carried out. 64 patients were scheduled for
hydrothermablation. The mean age of the patients was 42 B 5.8 years and all had
suffered from menorrhagia for an average of 50 B 42 months. All patients had
previously been treated by D&C (at least 2). Hydrothermablation was carried out
in 56 patients; 3 dropped out after screening and 5 because of technical problems
during the procedure. We have two complications: 1 patient with vaginal burning
by hot water and 1 with vaginal burning by the sheath. At follow-up of 12 months
in 46 patients (82.1%), the treatment was seen to be successful. Amenorrhea was
achieved in 37% of the patients. In all patients, improvement of the hemoglobin
level was found 1 year after the operation. The dysmenorrhea rate decreased from
41 to 20%.
We could confirm the good results of the pilot study in the multicenter trial. A
long-term follow-up is neccessary and now a new trial has been started in the
United States. It is a prospective randomized comparison study of hydrotherm-
ablation and endometrial resection.

Discussion

With the now introduced, first clinical study of hydrothermal ablation for
coagulating endometrium, a new, evidently safe method is offered, which works
as most modern techniques according to old principles. The control mechanisms
stop the coagulation process immediately if there is a liquid loss of 10 cm3. Since
the intrauterine pressure is kept low at 50 mm Hg, there is no liquid loss through
the tubes. Even when a laparoscopic sterilization was carried out at the same time,
we were able to observe that no liquid flowed through the fimbria. To avoid burn-
ing the vagina, care should be taken that the cervical canal is not dilated excessive-
ly, so that there is a tight seal between the hysteroscopic sheath and the cervix. A
tenaculum applied to the cervix after the sheath has been positioned, and before
heating of the saline solution begins, provides a secure seal to prevent leakage. If
leakage occurs around the sheath due to any structural abnormality, the 10-cm3
limit will be reached and the system will shut down before the heating phase can
begin.
All serious, partly life-threatening complications, which are associated with
an operative hysteroscopy, such as perforations, TUR syndrome, etc. cannot

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occur as a result of hydrothermal ablation, so that special training is not required
[4, 5]. Any hysteroscopist who is involved in diagnosis on a daily basis can learn
and employ this method with little effort. Hydrothermal ablation, described by
Goldrath et al. [6], the inaugurator of ablation of the endometrium, holds much
promise for the future. Long-term studies will show to what extent the results can
compete with those of endometrial ablation by laser or electrosurgery.
In order to achieve good intraoperative viewing and attain a high rate of
amenorrhea, pretreatment with GnRH analogs, which is generally given once or
twice at the present time, is recommended. This also corresponds to the standard
customary for endometrial ablation with coagulation techniques [4, 8]. In distinc-
tion to the balloon methods, due to the direct contact and distribution of the
liquid, the cornua can be coagulated completely. Goldrath et al. [6] were also able
to confirm this on histological sections [9]. The balloon methods, in which these
areas are possibly not reached due to less compliance of the balloon, are less
advantageous here [10, 11]. Even in patients with lesser malformation of the uter-
us (arcuate uterus), the results of the balloon method may well be limited [10, 11].
There are no contraindications in this situation for the hydrothermal ablation
method. Further studies confirm our good results for HTA treatment [12].
The development of new, simplified technologies for coagulating the endo-
metrium must be evaluated critically in long-term studies, in which strict atten-
tion must be paid to ensure that the same indications apply here as for the techni-
cally more difficult hysteroscopic ablations, using laser or electrosurgery. The
simplicity of the method should not cause it to become the be all and end all for
the treatment of therapy-resistant bleeding disorders. There is still place for the
more difficult ablation procedure, but the technique should prove useful in the
majority of cases that have a normal or near normal uterus.

References

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Prof. Thomas Römer, MD, Department of Obstetrics and Gynaecology

University of Cologne, Kerpener Str. 34, D–50931 Cologne (Germany)
Tel. +49 221 478 3833, Fax +49 221 478 6789
E-Mail Thomas.Roemer@medizin.uni-koeln.de

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