Single Incision Slings Il presente nel trattamento della IUS

3. Single Incision SlingsSingle Incision Slings

4. • Anchoring mechanism
• Tape fixation
• Tensioning maneuver
Different devicesDifferent devices

5. • Paicity of high quality clinical
studies
• Short vs. long term efficacy
• Selection and interpretation bias
Single incision sling procedures
Major concerns

6. • SIMS were associated with significantly lower subjective andSIMS were associated with significantly lower subjective and
objective cure rates at 6-12 mo compared with SMUSobjective cure rates at 6-12 mo compared with SMUS
RR. 0.83 and 0.85 (95% CI 0.70-0.99)RR. 0.83 and 0.85 (95% CI 0.70-0.99)
• Shorter operative timeShorter operative time
• Lower day 1 pain scoresLower day 1 pain scores
• Less postoperative groin painLess postoperative groin pain
• Higher repeat continence surgery and de novo urgencyHigher repeat continence surgery and de novo urgency
• No difference in the QoL scoresNo difference in the QoL scores
758 women in nine RCTs with a mean follow-up of 9.5 mo758 women in nine RCTs with a mean follow-up of 9.5 mo

7. J&J to Stop Selling Surgical Mesh
June 5, 2012

8. 3308 women in 26 RCTs with a mean follow-up of 18.6 mo3308 women in 26 RCTs with a mean follow-up of 18.6 mo
After excluding RCTs evaluating TVT-securAfter excluding RCTs evaluating TVT-secur
• No evidence of significant differences between SIMS and SMUS in
patient-reported cure rates (RR. 0.98; 95% CI 0.88-1.00) and
objective cure rates (RR. 0.98; 95% CI 0.94-1.01)
• Lower postoperative pain scores
• Early return to normal activities and to work
• Non significant trend towards higher rates of
repeat continence surgery
SIMS were associated withSIMS were associated with

9. Single-incision sling operations for urinary
incontinence in women (Review)
Nambiar A, Cody JD, Jeffery ST
Single-incision slings resulted in higher incontinence rate compared with inside
out transobturator slings (30%vs 11%; RR 2.55, 95% CI 1.93 to 3.36)
Women were more likely to remain incontinent after surgery with single-incision
slings than with retropubic slings (41% vs 26%; RR 2.08, 95% CI 1.04 to 4.14).
2014 The Cochrane Collaboration
31 trials identified involving 2290 women31 trials identified involving 2290 women
Most of these findings were derived from the trials involving
TVT-Secur

10. Are all women the same?

11. Retropubic:
Transobturator:
Single incision:
Are all slings the same?

12. 2007
• Overall subjective success rate was > 92%Overall subjective success rate was > 92%
• No difference in subjective failure between the two routes:No difference in subjective failure between the two routes:
OR = 0.85 (95% CI 0.38-1.92)OR = 0.85 (95% CI 0.38-1.92)
6 RCTs and 11 cohort studies

13. RP – SLINGS
3.5%
1.6%
1.5%
RP vs. TOT Slings Complications
(Meta-analysis)
TO – SLINGS
0.2%
0.08%
16%
Bladder injuries
Pelvic hematoma
Groin pain
(resolves 2 months
postop)
1. SungVW et al., Am J Obstet Gynecol2007; 197:
3-11
2. Latthe PM et al., BJOG 2007; 114 (5):522-531
3. Novara G et al., Eur Urol.2008;53(2): 288-308

14. Risk Factors for Sling Failure
• Older age
• Obesity
• Mixed Incontinence
• Intrinsic sphincter deficiency
• Previous anti-incontinence surgery
Stav, 2010
Barber,2008
Houwert, 2009

15. Reference Trial N° TVT TOT Comments
Schierlitz et al, 2008 RCT 164 79 55 P=0.004; OR 2.6 for repeat
surgery with TOT
Gungorduk et al, 2009 Retr. 300 78 52 P < 0.0001; risk of failure
4.9 higher with TOT
Jeon et al, 2008 Retr. 166 86 35 P < 0.001; failure risk 4.6
higher with TOT
ISD: Comparison of RP and TOT slingsISD: Comparison of RP and TOT slings
Cure rates%
Patients with ISD may do better with RP slings but the evidence is not strong
enough to support a high-level recommendation

16. The subjective cure rate was 79.8% (95% CI 71-89) in 350
subjects after a mean of 27 months f.u.
The subjective cure rate was 54.8% (95% CI 37-81) in 46
subjects after a mean of 16 months f.u.
Int Urogyn J 2012; 23:831
Outcome after TVT
Outcome after TOT

17. Goal of Single-Incision Slings
Intent to further reduce invasiveness theoretically resulting in:
• Enhanced safety profile
• Improved peri/post-operative patient comfort
• Use of local anesthesia
• Maintenance of the present level of efficacy

18. Ideal comparisonIdeal comparison
vsvs

19. SIS vs Transobturator slingsSIS vs Transobturator slings
Published RCTsPublished RCTs
AuthorAuthor SlingSling N°N° f.u.f.u.
mo.mo.
SubjectiveSubjective
Cure ratesCure rates
Oliveira et al,Oliveira et al,
Eur Urol 2011Eur Urol 2011
MinarcMinarc
TVT-OTVT-O
3030
3030
1212 87%87%
83%83%
Schellart et al,Schellart et al,
Eur Urol 2014Eur Urol 2014
MiniarcMiniarc
MonarcMonarc
9797
9696
1212 83%83%
86%86%
Mostafa et al,Mostafa et al,
Urol 2013Urol 2013
AjustAjust
TVT-OTVT-O
6969
6868
1212 84%84%
85%85%

20. SIS vs Transobturator slingsSIS vs Transobturator slings
Published RCTsPublished RCTs
AuthorAuthor SlingSling N°N° f.u.f.u.
mo.mo.
SubjectiveSubjective
Cure ratesCure rates
Djehdian et alDjehdian et al
Obstet GynecolObstet Gynecol
20142014
Schweitzer et al,Schweitzer et al,
Obstet GynecolObstet Gynecol
20152015
OphiraOphira
UnitapeUnitape
AjustAjust
AlignAlign
6464
5656
100100
5656
1212
1212
81%81%
88%88%
77%77%
73%73%
Lee et al,Lee et al,
AJOG 2015AJOG 2015
MiniarcMiniarc
MonarcMonarc
112112
113113
1212 92%92%
94%94%

21. ResultsResults
Cure rate 95% CI Cure rate 95% CI
Objective 85 % 81.78-88.22 87% 83.78-90.22
Subjective 84% 80.69-87.31 85% 81.58-88.42
Composite 84.5% 81.24-87.76 86% 81.68-89.32
SISSIS
N= 472N= 472
TOTTOT
N= 419N= 419

22. Thigh painThigh pain
Significantly lower for SIS vs TOT in the first week post-opSignificantly lower for SIS vs TOT in the first week post-op
Reoperation rateReoperation rate
Similar for both proceduresSimilar for both procedures
Operating timeOperating time
Significantly shorter for SIS vs TOTSignificantly shorter for SIS vs TOT

23. Conclusions
• Uncomplicated cases
Primary operation
Urethral hypermobility
No ISD
Non obese woman
No other surgery
Consider SISConsider SIS
SIS seem to be as effective as standard TOT slings for theSIS seem to be as effective as standard TOT slings for the
treatment of primary SUItreatment of primary SUI