1. Uterine Balloon therapy
An alternatives to Hysterectomy
Dr. Sharda Jain
Dr. Jyoti Agarwal
DR. Jyoti Bhaskar

2. Hysterectomy is the choice

3. Alternatives should be probed

5. Heavy menstrual bleeding
An important cause of morbidity
• It affects 1 in 5
women.
• 30% of women in
reproductive age group
suffer with Menorrhagia
• 60% of these women
will ultimately undergo
hysterectomy

6. Hysterectomy
• Second most
frequent surgical
procedure in women of
reproductive age group
• 90% for benign reasons
• Promptly offered
following a diagnosis.

7. Value Study(BJOG - 2004)
survey of outcomes of 37,000 hysterectomies
• Operative and
postoperative
complication rate of
3.5% and 9 %
respectively were reported
• Postoperative
mortality of 0.38 /
1000.
• Psychological
implications 35-45%
•
Hysterectomy should not be taken up

10. Dilemma!! of Treatment
Aim - Quality Personal life
- Family life
- Preserve the feminity of a women
- ↓ Frequent leave from office
Age
Severity
Fertility

11. Treatment of Heavy Periods
Individualized
• age
• need for contraception
• desire to retain uterus
• Nature and severity of complaints
• presence of any pelvic pathology
• outcome of previous treatment
• cost of treatment
• time away from work

12. Present Practice
TVS/D&C
Drugs
Another D&C
Hysterectomy

13. Options AvailableOptions Available
Mirena /
Endometrial Ablation
Drug therapyDrug therapy
Hysterectomy

14. Options available
Alternatives to Hysterectomy

15. NICE guideline (Jan 2007)
management of heavy menstrual bleeding
• If future childbearing is desired
LNG – IUS is the first line intervention
• If future child bearing is not
desired
Endometrial ablation

16. Uterine balloon
therapy

17. 10 minute
Solution
for
‘Heavy
Periods’

18. Day Care Procedure
• Definitive solution for patients
• Minimally Invasive
• High safety profile
• Requires minimal training
• Clinically proven (90-97%)
• Can be performed under LA
• Cost Effective
See to Believe it

19. • Long learning curveLong learning curve
•Succes rate 85%Succes rate 85%
• Re-surgery up to 30%Re-surgery up to 30% ..
•LO
FEAT
FIRST GENERATION ENDOMETRIAL ABLATIONFIRST GENERATION ENDOMETRIAL ABLATION
TECHNIQUESTECHNIQUES
(Hysteroscopic Techniques)(Hysteroscopic Techniques)
Given up by most expertsGiven up by most experts

20. Ideal global endometrial
ablation technique
•SSAFEAFE
•SSUCCESFULLUCCESFULL
•SSIMPLEIMPLE
•SSAVINGAVING

21. SEATSEAT
Second generation endometrial ablationSecond generation endometrial ablation
techniquestechniques

22. UTERINE BALLOON THERAPYUTERINE BALLOON THERAPY
SYSTEMSYSTEM
““UBT”UBT”
(GynecareThermachoice(GynecareThermachoiceRR
))
First global ablation technology to
receive FDA approval 1997
19971997

23. Therma choice
• A balloon tipped
catheter is positioned
into the uterine cavity
and filled with fluid
that is heated to 87
degrees centigrade
• Ablation cycle takes
8 minutes.

24. Extensive Safety/Feasibility Study:Extensive Safety/Feasibility Study:
In-Vivo +2 MillionIn-Vivo +2 Million
• Mean peak serosal temperature: 36.1Mean peak serosal temperature: 36.1 ++ 1.6
• Deep endometrial and superficial myometrialDeep endometrial and superficial myometrial
injury in all areasinjury in all areas
• Deepest myometrial injury: 3.4 mmDeepest myometrial injury: 3.4 mm
• In no uterine cornu was depth > 2.0 mmIn no uterine cornu was depth > 2.0 mm

25. Pre-Ablation

26. Post-Ablation

27. Uterine Balloon Therapy
• 95 % success rate
• 50 % amenorrhic at 1
year
• Affects fertility
Pre-Ablation Post Ablation
Use of effective contraception
following procedure is must

28. Uterine Balloon Therapy
Requires hospital stay only 4
hours
• Crampy feeling- 2-8 hours
• Mild pain – 2-14 days
• Vaginal discharge
( watery or blood stained – 2-14 days)

29. Patient Selection
• Unresponsive to medical therapy
• Completed family
• Normal pap smear
• Negative endometrial biopsy
• Cavity depth 6-12 cm

30. Not fully Evaluated
• Large uterus (> 30 cc, >12 cm)
• Previously failed TCRE
• Repeat Endometrial Ablation
• Post Menopausal Bleeding

31. Factors Affecting
Failure Rate Increases
• ↓40 years
• Prolonged duration (↑ 10 years)
• RV uterus (6 fold)
• < Intrauterine pressure during therapy
(ideal > 160)

32. Factors Affecting
Failure Rate decreases
• Pre- operative medical therapy
Danazol /gnRH - G
• Post Operative therapy with injection
Depo-provera 3 monthly for 4-6 injections
(95 to 99%)

33. INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH AT LEAST 24 MONTH FOLLOW-UP
INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH AT LEAST 24 MONTH FOLLOW-UP
8 min treatment; >150 mmHg Start Pressure
Hypomenorrhea
38%
Amenorrhea /spotting
36%
Minimal or no
reduction in
menses 4.0%
22%
NormalperiodsNormalperiods

34. > OVER 20,00,000
procedures worldwide
We Have Largest No. of Cases of UBT in India
Updated on 1/9/2013,N - 1304

35. • Proliferative Endometrium – 156
• Disorderd Secretory Endometrium – 37
• Simple Hyperplasia – 618
• Complex Hyperplasia without Atypia- 27
Post Menopausal Bleeding – 209
• Proliferative Endometrium
• Simple Hyperplasia
Poor surgical risk - 257
N – 1304N – 1304 (Success Rate – 99%)(Success Rate – 99%)
Updated on 1/9/2013Updated on 1/9/2013

36. UTERINE BALLOON THERAPY IN
POOR SURGICAL RISK CASES
I.E.PALLIATIVE TREATMENT
• Morbid Obesity, Diabetic, Hypertensive, Fibroids
(95-126 kg)
• Chronic Renal failure
• Poor Cardiac Reserve
• I.T.P. For BM Transpant
(Pancytopenia & CML)
• RHD (valve replacement)
N-257 Cases
Compiled on 31Compiled on 31stst
Dec. 2011Dec. 2011

37. Hysterectomy needed in – 2
(Both with fibroids)
Repeat Balloon Therapy – 3

38. UBT’s
Biggest Use
Is for patients who are
high risk for surgery

39. Our Experience
UBT v/s Mirena
Great
Great
Great
4th
Month
Jaan Nikaal
Deta Hai
Really
troublesome
But one should TRY

40. KJ Carlson, NEJM 328:856,
1993
HYSTERECTOMY
as Treatment
Should be last resort

41. Uterine Balloon Therapy is thus a newUterine Balloon Therapy is thus a new
horizon to your patient and yourself.horizon to your patient and yourself.
Once family is completedOnce family is completed
BE BOLD, WALK ALONG NEW
PATHS
EXPERIENCE IT YOURSELF

42. Thank You