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Wich sling for wich patient?. Prof. Paulo Palma UNICAMP, SP, Brazil. Pessaries. HIPOCRATES 375 A C Minimally invasive. “The gold standard”. AUA STRESS INCONTINENCE GUIDELINE COMMITTEE: META-ANALYSIS OF THE LITERATURE: SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATE

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wich sling for wich patient

Wich sling for wich patient?

Prof. Paulo Palma

UNICAMP, SP, Brazil

slide2

Pessaries

HIPOCRATES 375 A C

Minimally invasive

the gold standard
“The gold standard”

AUA STRESS INCONTINENCE GUIDELINE COMMITTEE:

META-ANALYSIS OF THE LITERATURE:

SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATE

BUT A HIGHER INCIDENCE OF VOIDING DYSFUNCTION

evidence based analysis efficacy
Evidence based analysis“efficacy”
  • interview / questionnaire / chart / examination / UDS
  • accuracy and reliability of the survey instrument
  • accuracy and reliability (bias) of patient or interviewer
  • “moment in time” : info obtained vs. published
  • follow-up: time (minimum / average / range) & dropouts
evidence based analysis quality of life
Evidence based analysis“quality of life”
  • Quality of life: SF – 36
  • Bristol
  • King’s College
  • SEAPI
  • others
evidence based analysis tolerability complications
Evidence based analysis“tolerability - complications”
  • what is the complication rate?
  • is the symptom persistent, exacerbated, or new?
  • how bothersome to the patient? will it resolve?
  • if not, what is the nature of the corrective treatment?
  • if it is medicine: will it be chronic?
  • if it is surgery, how difficult for the patient?
evidence based analysis comparisons of operations
Evidence based analysis“comparisons of operations”
  • what is the “gold standard” / does it exist?
  • is the old or new technique reproducible?
  • how is one operation compared to another?
  • retrospective vs prospective? randomized?
  • who is doing the procedure? individual or group?
  • is there a learning curve?
  • are the complications similar?
evidence based analysis
Evidence Based Analysis
  • Follow-up “drop-outs” “exclusions” “intent to tx”
  • Patients lost to follow-up may have > complication rate
  • Complaints that are omitted because of insufficient data
  • Patients who refuse surgery may bias outcome
  • How does the patient know the alternative treatment ?
suburethral slings
SUBURETHRAL SLINGS
  • +/- complete, partial or patch
  • +/- penetration of urogenital diaphram
  • +/- objectifying appropriate tension
  • +/- autologous / bio-graft / artificial
  • +/- bladder neck or mid-urethral
a brief history of time
A BRIEF HISTORY OF TIME
  • 1907 Von Giordano
  • 1978 McGuire & Lytton

Combined Approach

  • 1993 Petros

IVS/TVT

  • 2001 Delorme

TOT

  • 2002 PalmaReadjustment (bi-directional)

SAFYRE t

  • 2003 Marques-Queimadelos Unidirectional

Readjustment- Remeex

a brief history of time first paradigm shift
A BRIEF HISTORY OF TIMEFIRST PARADIGM SHIFT
  • 1978: autologous pubovaginal sling *
  • Aponeurotic free graft
  • Combines approach

3. Tension-free

4. ISC

*1978 McGuire & Lytton

slide12

Rationale

Bladder

Pubis

Pubourethral

Ligament

slide13

uretropelvic

Ligament

Sacrum

A BRIEF HISTORY OF TIMESECOND PARADIGM SHIFT

Petros &

Ulmsten

Uterus

P

Bladder

Utero-sacral

Ligament

Vag.

pubourethral

Ligament

Tendinous Arc

a brief history of time tot third paradigm shift
A BRIEF HISTORY OF TIMETOT:THIRD PARADIGM SHIFT

Emmanuel Delorme 2001

  • Cystoscopy not mandatory
  • Avoids Retzius space
  • Less irritative symptoms
  • Less visceral and vascular trauma
rationale

Transobturator Sling

urethropelvic

ligament

pubourethral ligament

Pubovaginal Sling

RATIONALE
what is the ideal sling
What is the ideal sling?

Non adjustables

  • Autologous
  • Minimally invasive
non adjustable
Non Adjustable

Autologous

Efficacy

Graft

Hospital stay

Complications

non adjustable1
Non Adjustable

Obstruction

  • 436 slings
  • 20 urethrolysis
  • Autologous: 18/210 8.5%
  • Adjustable synthetic: 2/226 0.8%

Autologous: more obstructive

Urethrolysis instead of adjustment

Palma et al. Eur Urol (A) 2005

a randomised trial of colposuspension and tvt
A Randomised Trial of Colposuspension and TVT
  • Prospective randomized 14 center study
  • 344 patients 15 month period, ending Aug. 1999
  • Methodology - meas. questionnaire; freq. / vol. chart, filling / voiding cystometry, urethral pressure profilometry, ICS 1hr. Pad test, SF-36, EuroQol, Bristol FLUTS questionnaire.
  • Measures - Pre-Op, 6 mo., 12 months, 24 month
  • Evaluable Patients at 24 mo. - 137 TVT vs. 108 Burch

Karen Ward - Paul Hilton

slide22

A Randomised Trial of Colposuspension and TVT

  • Cure rates and quality of life changes
  • TVT remained comparable with colposuspension at 24 months
  • Economic considerations

Surgery details show TVT to be less expensive due to shorter time and duration of treatment anesthetic room, OR time, recovery room, hospital stay, and hemoglobin during the operation

slide23
TVT

Most Serious Reported Complications* (based on over 200,000 patients treated world-wide)

Complication US Ex-US Total

Vascular Injury 3 25 28

Vaginal Mesh Exposure 19 2 21

Urethral Erosion 12 0 12

Bowel Perforation 8 6 14

Nerve Injury 1 0 1

* As of April 15, 2002, 5 deaths have been reported to GYNECARE that are associated with TVT..

slide24
The Relationship of TVT Insertion to the Vascular Anatomy of the Retropubic Space and the Anterior Abdominal Wall
  • Study performed on 10 fresh cadavers
  • Measured distance from the needle to vessel
  • Results: All vessels were lateral to the needle
  • Conclusion: “If the TVT needle is laterally directed or externally rotated in the course of insertion, major vascular injury may result”

T.W. Muir, , et al. Paper presentation, 22nd Annual Meeting, AUGS, Oct. 2001.

slide26

Pubic Ramus

Accessory

Obturator

Vein

Obturator

Nerve

Pubocervical

Fascia

External Iliac

Vein

TVT Needle

slide27

Anterior Abdominal Wall

Pubic Symphysis

TVT Needle

Bowel

slide28
TVT
  • Rezapour, Ulmsten U. Tension-Free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD)-a long-term follow-up.
  • 49 patients (3- 5 years F/U)

... older patients (>70 years) with a very low resting urethral pressure and an immobile urethra seem to constitute a risk group where TVT surgery is less successful...

Int Urogynecol J. 2001, 12 Suppl 2:S12-14.

slide29
TVT

Neuman M.Trans vaginal tape readjustment after unsuccessful tension-free vaginal tape (TVT) operation.

  • 334 patients
  • 4 adjustaments
  • Cure: 3
  • Failure: 1

There are no reports with others TVT- like slings

Neurourol Urodyn 2004;23(3):282-3.

non adjustable tot
Non Adjustable TOT
  • Ozel B et. al.Treatment of voiding dysfunction after transobturator tape procedure.
  • 2 patients (PO 17 / PO 18)
  • Successful loosening of the mesh

Urology 2004, 64(5):1030.

adjustable sling rationale
Adjustable sling: rationale
  • There is a 10-15% failure rate
  • Complicated subset of patients

ISD

Detrusor hypocontractibility

Orthotopic neobladder

Obesity

Chronic pulmonary diseases

Others

adjustable slings
Adjustable slings

2.Reemex

  • Safyre
safyre
SAFYRE

Features

  • Hybrid & versatile
  • Universal approach
safyre1
SAFYRE

Features

  • Re-adjustability
  • Hybrid & versatile
  • Universal approach
adjustable sling
Adjustable sling

The Ibero-American experience with a re-adjustable minimally invasive sling.

  • 126 patients
  • PVR > 100 ml
  • 4 patients (3%)
  • 4 successful
  • readjustments

Palma et al. BJU Int 2005, 95:341-5.

slide37

TRANSVAGINAL x TRANSOBTURATOR

Palma & Netto, Illustrated Urogynecology , 2005

safyre t versus safyre vs
SAFYRE T versus SAFYRE VS
  • 226 patients

126 vs (mean age 63)

F/U 18 months

75 (59%) previous surgery

100 t (mean age 61)

F/U 14 months

65 (65%) previous surgery

Palma et al. Int Urogynecol J. 2005

safyre t versus safyre vs1
SAFYRE T versus SAFYRE VS

RESULTS

Cure (p>0,05)

VS: 92,1%

T : 94 %

Improvement (p>0,05)

VS: 2,4%

T : 2%

Palma et al. Int Urogynecol J. 2005

safyre t versus safyre vs2
SAFYRE T versus SAFYRE VS

RESULTS

Mean operative time (p<0,05)

VS: 25 min

T : 15 min

Transient Voiding symptoms

(p<0,05)

VS: 20.6 %

T : 10 %

Student’s t test

Palma et al. Int Urogynecol J. 2005

safyre t versus safyre vs3
SAFYRE T versus SAFYRE VS

COMPLICATIONS

Bladder injury (p<0,05%)

VS: 12 (10%)

T : 0

Mesh infection (p>0,05)

VS: 4 (3,1%)

T : 1 (1%)

Palma et al. Int Urogynecol J. 2005

safyre t versus safyre vs4
SAFYRE T versus SAFYRE VS
  • SAFYRE T IS AS EFFECTIVE AS SAFYRE VS
  • SAFYRE T LESS OPERATIVE TIME
  • SAFYRE T NO VASCULAR OR VISCERAL TRAUMA
  • READJUSTABILITY IMPROVES OUTCOME

Palma et al. Int Urogynecol J. 2005

slide43

Are all the patients the same?

Intrinsic Sphincter Deficiency

Pure

ISD

Hypermobility

Good

Mild

Bad

what should be evaluated
WHAT SHOULD BE EVALUATED ?

New devices

Outpatient

Safety

Costs

Op time

Adjust

Efficacy

Learning

EBM

Sick leave

Complications

MAJOR

MINOR

where the past meets the present
Where the past meets the present

Soranus

Primum non nocere

Minimally invasive Maximally effective

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