Uterine Balloon therapy
An alternatives to Hysterectomy
Dr. Sharda Jain
Dr. Jyoti Agarwal
Dr. Jyoti Bhaskar
Hysterectomy is the choice
Hysterectomy for Normal size
Ut.- Unjustified
Alternatives should be probed
Heavy menstrual bleeding
An important cause of morbidity
• It affects 1 in 5
or 1 in 3 women.
• 30% of women in
reproducti...
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 major
complication rate...
We have to give- up herd following of
Uterus Removal
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’
UBT
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...
No Ideal global endometrial
ablation technique - so far !!
•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 of JJ
stopped operations of
gynae care products
NOVA SURE
of USA - yet to come
CAVATERM
Now in India
UBT - Thermocoagulation Principle
3 essential parameters
HEAT
TIME
PRESSURE
PERMANENT
TREATMENT OF DUB
UBT - Thermocoagulation Principle
The thermal coagulation principle
Combined action of pressure and heat
applied for a suf...
Extensive Safety/Feasibility Study:Extensive Safety/Feasibility Study:
of UBTof UBT
Pre-Ablation
Post-Ablation
All Uterine Balloon Therapy
are Same
• 95 % success rate
• 50 % amenorrhic at 1
year
• Affects fertility
Pre-Ablation Post...
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)
• < Intrauter...
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 2 million / yr
procedures are done in USA alone
We Have Largest No. of Cases of UBT in India
Updated on 1/8/2014
• Proliferative Endometrium – 197
• Disorderd Secretory Endometrium – 41
• Simple Hyperplasia – 674
• Complex Hyperplasia ...
UBT’s
Biggest Use
Is for patients who are
high risk for surgery
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
Our Experience
UBT v/s Mirena
Great
Great
Great
4th
Month
Jaan Nikaal
Deta Hai
Really
troublesome
Now we have learnt To ov...
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...
UBT - Cavaterm™
Endometrial Ablation Method NOW In INDIA
What is Cavaterm ?
• Minimally invasive therapy for the
treatment...
Cavaterm™
Evolution of a successful system
•Quick to learn and easy to use
method to treat DUB
•Used since 1993
• Ongoing ...
UBT - Cavaterm™
Contraindications
 Undiagnosed uterine bleeding
 Ongoing infection
 Pregnancy or desire to become pregn...
ADDRESS
11 Gagan Vihar, Near Karkari
Morh Flyover, Delhi - 51
CONTACT US
9650588339, 011-22414049,
WEBSITE :
www.lifecarec...
Uterine Balloon therapy An alternatives to Hysterectomy Dr. Sharda Jain/ Dr. Jyoti Agarwal / Dr. Jyoti Bhaskar
Uterine Balloon therapy An alternatives to Hysterectomy Dr. Sharda Jain/ Dr. Jyoti Agarwal / Dr. Jyoti Bhaskar
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Uterine Balloon therapy An alternatives to Hysterectomy Dr. Sharda Jain/ Dr. Jyoti Agarwal / Dr. Jyoti Bhaskar

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  • Mirena
  • Benefits of hysterectomy. There are women out there who want amenorrhea and will be satisfied with nothing less. After understanding and accepting the balanced risks, benefits, and alternatives, those patients may be more appropriate candidates for hysterectomy than for any type of endometrial ablation, since no type of ablation can guarantee amenorrhea.
  • WHY SHOULD’NT A HYSTERECTOMY BE AVOIDED IF THE BENEFIT CAN BE PROVIDED TO A GOOD NO, OF PATIENTS BY A SAFER ALTERNATIVE TT MODALITY COZ HYSTERECTOMY DOES CARRY RISKS OF ANAESTHESIA ETC
  • Uterine Balloon therapy An alternatives to Hysterectomy Dr. Sharda Jain/ Dr. Jyoti Agarwal / Dr. Jyoti Bhaskar

    1. 1. Uterine Balloon therapy An alternatives to Hysterectomy
    2. 2. Dr. Sharda Jain Dr. Jyoti Agarwal Dr. Jyoti Bhaskar
    3. 3. Hysterectomy is the choice
    4. 4. Hysterectomy for Normal size Ut.- Unjustified Alternatives should be probed
    5. 5. Heavy menstrual bleeding An important cause of morbidity • It affects 1 in 5 or 1 in 3 women. • 30% of women in reproductive age group suffer with Menorrhagia • 60% of these women will ultimately undergo HYSTERECTOMY
    6. 6. Hysterectomy • Second most frequent surgical procedure in women of reproductive age group • 90% for benign reasons • Promptly offered following a diagnosis.
    7. 7. Value Study(BJOG - 2004) survey of outcomes of 37,000 hysterectomies • Operative and postoperative major 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
    8. 8. We have to give- up herd following of Uterus Removal
    9. 9. Dilemma!! of Treatment Aim - Quality Personal life - Family life - Preserve the feminity of a women - ↓ Frequent leave from office Age Severity Fertility
    10. 10. 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
    11. 11. Present Practice TVS/D&C Drugs Another D&C Hysterectomy
    12. 12. Options AvailableOptions Available Mirena / Endometrial Ablation Drug therapyDrug therapy Hysterectomy
    13. 13. Options available Alternatives to Hysterectomy
    14. 14. 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
    15. 15. Uterine Balloon Therapy
    16. 16. 10 minute Solution for ‘Heavy Periods’ UBT
    17. 17. 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 UBT
    18. 18. • 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 upGiven up by most expertsby most experts
    19. 19. No Ideal global endometrial ablation technique - so far !! •SSAFEAFE •SSUCCESFULLUCCESFULL •SSIMPLEIMPLE •SSAVINGAVING
    20. 20. SEATSEAT Second generation endometrial ablationSecond generation endometrial ablation techniquestechniques
    21. 21. UTERINE BALLOON THERAPYUTERINE BALLOON THERAPY SYSTEMSYSTEM ““UBT”UBT” (GynecareThermachoice(GynecareThermachoiceRR )) First global ablation technology to receive FDA approval 1997 19971997
    22. 22. Therma choice of JJ stopped operations of gynae care products
    23. 23. NOVA SURE of USA - yet to come CAVATERM Now in India
    24. 24. UBT - Thermocoagulation Principle 3 essential parameters HEAT TIME PRESSURE PERMANENT TREATMENT OF DUB
    25. 25. UBT - Thermocoagulation Principle The thermal coagulation principle Combined action of pressure and heat applied for a sufficient time - Pressure: variable in different machines - Temperature: 78° C - 87 ° C - Time: 8 - 10 minutes  5-8 mm of the endometrium and myometrium will be destroyed during treatment Endometrium Myometrium Basal membrane Functional layer
    26. 26. Extensive Safety/Feasibility Study:Extensive Safety/Feasibility Study: of UBTof UBT
    27. 27. Pre-Ablation
    28. 28. Post-Ablation
    29. 29. All Uterine Balloon Therapy are Same • 95 % success rate • 50 % amenorrhic at 1 year • Affects fertility Pre-Ablation Post Ablation Use of effective contraception following procedure is must
    30. 30. 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)
    31. 31. Patient Selection • Unresponsive to medical therapy • Completed family • Normal pap smear • Negative endometrial biopsy • Cavity depth 6-12 cm thermachoice/ Novasure • 4-10cm for cavaterm
    32. 32. Not fully Evaluated • Large uterus (> 30 cc, >12 cm) • Previously failed TCRE • Repeat Endometrial Ablation • Post Menopausal Bleeding
    33. 33. Factors Affecting Failure Rate Increases • ↓ 40 years • Prolonged duration (↑ 10 years) • RV uterus (6 fold) • < Intrauterine pressure during therapy (ideal > 160)
    34. 34. 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%)
    35. 35. 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
    36. 36. OVER 2 million / yr procedures are done in USA alone We Have Largest No. of Cases of UBT in India Updated on 1/8/2014
    37. 37. • Proliferative Endometrium – 197 • Disorderd Secretory Endometrium – 41 • Simple Hyperplasia – 674 • Complex Hyperplasia without Atypia- 30 Post Menopausal Bleeding – 209 • Proliferative Endometrium • Simple Hyperplasia Poor surgical risk - 263 N – 1508N – 1508 (Success Rate – 99%)(Success Rate – 99%) Updated on 1/8/2014Updated on 1/8/2014
    38. 38. UBT’s Biggest Use Is for patients who are high risk for surgery
    39. 39. 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-263 cases Compiled on 1/8/2014Compiled on 1/8/2014
    40. 40. Hysterectomy needed in – 2 (Both with fibroids) Repeat Balloon Therapy – 3
    41. 41. Our Experience UBT v/s Mirena Great Great Great 4th Month Jaan Nikaal Deta Hai Really troublesome Now we have learnt To overcome the problems of Mirena in the firs 3 – 6 months
    42. 42. KJ Carlson, NEJM 328:856, 1993 HYSTERECTOMY as Treatment Should be last resort
    43. 43. 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
    44. 44. UBT - Cavaterm™ Endometrial Ablation Method NOW In INDIA What is Cavaterm ? • Minimally invasive therapy for the treatment of DUB • Thermal balloon ablation of the endometrium • Using pressure and heat for 10 minutes to treat DUB • System consisting of a Cavabox and a single use catheter The Cavaterm™ System
    45. 45. Cavaterm™ Evolution of a successful system •Quick to learn and easy to use method to treat DUB •Used since 1993 • Ongoing product development and innovations based on users feedback Now we have 3rd génération
    46. 46. UBT - Cavaterm™ Contraindications  Undiagnosed uterine bleeding  Ongoing infection  Pregnancy or desire to become pregnant  Doubts regarding uterine wall strength  Gross uterine abnormalities  Endometrial atypical cells  Uterine cavities > 10 cm and < 4 cm  Cervical canal longer than 6 cm
    47. 47. ADDRESS 11 Gagan Vihar, Near Karkari Morh Flyover, Delhi - 51 CONTACT US 9650588339, 011-22414049, WEBSITE : www.lifecarecentre.in www.drshardajain.com www.lifecareivf.com E-MAIL ID Sharda.lifecare@gmail.com Lifecarecentre21@gmail.com info@lifecareivf.com & Thank You

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