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Uterine Balloon therapy
An alternatives to Hysterectomy
Dr. Sharda Jain
Dr. Jyoti Agarwal
DR. Jyoti Bhaskar
Hysterectomy is the choice
Alternatives should be probed
Heavy menstrual bleeding
An important cause of morbidity
• It affects 1 in 5
women.
• 30% of women in
reproductive age gro...
Hysterectomy
• Second most
frequent surgical
procedure in women of
reproductive age group
• 90% for benign reasons
• Promp...
Value Study(BJOG - 2004)
survey of outcomes of 37,000 hysterectomies
• Operative and
postoperative
complication rate of
3....
Dilemma!! of Treatment
Aim - Quality Personal life
- Family life
- Preserve the feminity of a women
- ↓ Frequent leave fro...
Treatment of Heavy Periods
Individualized
• age
• need for contraception
• desire to retain uterus
• Nature and severity o...
Present Practice
TVS/D&C
Drugs
Another D&C
Hysterectomy
Options AvailableOptions Available
Mirena /
Endometrial Ablation
Drug therapyDrug therapy
Hysterectomy
Options available
Alternatives to Hysterectomy
NICE guideline (Jan 2007)
management of heavy menstrual bleeding
• If future childbearing is desired
LNG – IUS is the firs...
Uterine balloon
therapy
10 minute
Solution
for
‘Heavy
Periods’
Day Care Procedure
• Definitive solution for patients
• Minimally Invasive
• High safety profile
• Requires minimal traini...
• Long learning curveLong learning curve
•Succes rate 85%Succes rate 85%
• Re-surgery up to 30%Re-surgery up to 30% ..
•LO...
Ideal global endometrial
ablation technique
•SSAFEAFE
•SSUCCESFULLUCCESFULL
•SSIMPLEIMPLE
•SSAVINGAVING
SEATSEAT
Second generation endometrial ablationSecond generation endometrial ablation
techniquestechniques
UTERINE BALLOON THERAPYUTERINE BALLOON THERAPY
SYSTEMSYSTEM
““UBT”UBT”
(GynecareThermachoice(GynecareThermachoiceRR
))
Fir...
Therma choice
• A balloon tipped
catheter is positioned
into the uterine cavity
and filled with fluid
that is heated to 87...
Extensive Safety/Feasibility Study:Extensive Safety/Feasibility Study:
In-Vivo +2 MillionIn-Vivo +2 Million
• Mean peak se...
Pre-Ablation
Post-Ablation
Uterine Balloon Therapy
• 95 % success rate
• 50 % amenorrhic at 1
year
• Affects fertility
Pre-Ablation Post Ablation
Use...
Uterine Balloon Therapy
Requires hospital stay only 4
hours
• Crampy feeling- 2-8 hours
• Mild pain – 2-14 days
• Vaginal ...
Patient Selection
• Unresponsive to medical therapy
• Completed family
• Normal pap smear
• Negative endometrial biopsy
• ...
Not fully Evaluated
• Large uterus (> 30 cc, >12 cm)
• Previously failed TCRE
• Repeat Endometrial Ablation
• Post Menopau...
Factors Affecting
Failure Rate Increases
• ↓40 years
• Prolonged duration (↑ 10 years)
• RV uterus (6 fold)
• < Intrauteri...
Factors Affecting
Failure Rate decreases
• Pre- operative medical therapy
Danazol /gnRH - G
• Post Operative therapy with ...
INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH AT LEAST 24 MONTH FOLLOW-UP
INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH ...
> OVER 20,00,000
procedures worldwide
We Have Largest No. of Cases of UBT in India
Updated on 1/9/2013,N - 1304
• Proliferative Endometrium – 156
• Disorderd Secretory Endometrium – 37
• Simple Hyperplasia – 618
• Complex Hyperplasia ...
UTERINE BALLOON THERAPY IN
POOR SURGICAL RISK CASES
I.E.PALLIATIVE TREATMENT
• Morbid Obesity, Diabetic, Hypertensive, Fib...
Hysterectomy needed in – 2
(Both with fibroids)
Repeat Balloon Therapy – 3
UBT’s
Biggest Use
Is for patients who are
high risk for surgery
Our Experience
UBT v/s Mirena
Great
Great
Great
4th
Month
Jaan Nikaal
Deta Hai
Really
troublesome
But one should TRY
KJ Carlson, NEJM 328:856,
1993
HYSTERECTOMY
as Treatment
Should be last resort
Uterine Balloon Therapy is thus a newUterine Balloon Therapy is thus a new
horizon to your patient and yourself.horizon to...
Thank You
Uterine balloon tharepy
Uterine balloon tharepy
Uterine balloon tharepy
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Uterine balloon tharepy

  1. 1. Uterine Balloon therapy An alternatives to Hysterectomy Dr. Sharda Jain Dr. Jyoti Agarwal DR. Jyoti Bhaskar
  2. 2. Hysterectomy is the choice
  3. 3. Alternatives should be probed
  4. 4. 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
  5. 5. Hysterectomy • Second most frequent surgical procedure in women of reproductive age group • 90% for benign reasons • Promptly offered following a diagnosis.
  6. 6. 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
  7. 7. Dilemma!! of Treatment Aim - Quality Personal life - Family life - Preserve the feminity of a women - ↓ Frequent leave from office Age Severity Fertility
  8. 8. 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
  9. 9. Present Practice TVS/D&C Drugs Another D&C Hysterectomy
  10. 10. Options AvailableOptions Available Mirena / Endometrial Ablation Drug therapyDrug therapy Hysterectomy
  11. 11. Options available Alternatives to Hysterectomy
  12. 12. 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
  13. 13. Uterine balloon therapy
  14. 14. 10 minute Solution for ‘Heavy Periods’
  15. 15. 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
  16. 16. • 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
  17. 17. Ideal global endometrial ablation technique •SSAFEAFE •SSUCCESFULLUCCESFULL •SSIMPLEIMPLE •SSAVINGAVING
  18. 18. SEATSEAT Second generation endometrial ablationSecond generation endometrial ablation techniquestechniques
  19. 19. UTERINE BALLOON THERAPYUTERINE BALLOON THERAPY SYSTEMSYSTEM ““UBT”UBT” (GynecareThermachoice(GynecareThermachoiceRR )) First global ablation technology to receive FDA approval 1997 19971997
  20. 20. 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.
  21. 21. 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
  22. 22. Pre-Ablation
  23. 23. Post-Ablation
  24. 24. 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
  25. 25. 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)
  26. 26. Patient Selection • Unresponsive to medical therapy • Completed family • Normal pap smear • Negative endometrial biopsy • Cavity depth 6-12 cm
  27. 27. Not fully Evaluated • Large uterus (> 30 cc, >12 cm) • Previously failed TCRE • Repeat Endometrial Ablation • Post Menopausal Bleeding
  28. 28. Factors Affecting Failure Rate Increases • ↓40 years • Prolonged duration (↑ 10 years) • RV uterus (6 fold) • < Intrauterine pressure during therapy (ideal > 160)
  29. 29. 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%)
  30. 30. 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
  31. 31. > OVER 20,00,000 procedures worldwide We Have Largest No. of Cases of UBT in India Updated on 1/9/2013,N - 1304
  32. 32. • 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
  33. 33. 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
  34. 34. Hysterectomy needed in – 2 (Both with fibroids) Repeat Balloon Therapy – 3
  35. 35. UBT’s Biggest Use Is for patients who are high risk for surgery
  36. 36. Our Experience UBT v/s Mirena Great Great Great 4th Month Jaan Nikaal Deta Hai Really troublesome But one should TRY
  37. 37. KJ Carlson, NEJM 328:856, 1993 HYSTERECTOMY as Treatment Should be last resort
  38. 38. 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
  39. 39. Thank You

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