Single Incision SlingsSingle Incision Slings

• Anchoring mechanism• Tape fixation• Tensioning maneuver

Different devicesDifferent devices

• Paicity of high quality clinical studies

• Short vs. long term efficacy • Selection and interpretation bias

Single incision sling procedures

Major concerns

• SIMS were associated with significantly lower subjective and SIMS 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

J&J to Stop Selling Surgical MeshJune 5, 2012

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 moAfter 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

Single-incision sling operations for urinaryincontinence in women (Review)

Nambiar A, Cody JD, Jeffery ST

Single-incision slings resulted in higher incontinence rate compared with insideout 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-incisionslings 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 involvingTVT-Secur

Are all women the same?

Retropubic:

Transobturator:

Single incision:

Are all slings the same?

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

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 monthspostop)

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

Risk Factors for Sling Failure

• Older age• Obesity• Mixed Incontinence• Intrinsic sphincter deficiency• Previous anti-incontinence surgery

Stav, 2010Barber,2008 Houwert, 2009

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

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

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

Ideal comparisonIdeal comparison

vsvs

SIS vs Transobturator slingsSIS vs Transobturator slingsPublished 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

MinarcMinarcTVT-OTVT-O

30303030

1212 87%87%83%83%

Schellart et al, Schellart et al, Eur Urol 2014Eur Urol 2014

Miniarc Miniarc MonarcMonarc

979796 96

1212

83%83%86% 86%

Mostafa et al, Mostafa et al, Urol 2013Urol 2013

Ajust Ajust TVT-OTVT-O

69696868

1212 84% 84% 85% 85%

SIS vs Transobturator slingsSIS vs Transobturator slingsPublished RCTsPublished RCTs

AuthorAuthor SlingSling N°N° f.u.f.u.mo.mo.

Subjective Subjective Cure ratesCure rates

Djehdian et alDjehdian et alObstet Gynecol Obstet Gynecol 20142014

Schweitzer et al,Schweitzer et al,Obstet Gynecol Obstet Gynecol 20152015

OphiraOphiraUnitapeUnitape

AjustAjustAlignAlign

64645656

1001005656

1212

1212

81%81%88%88%

77%77%73%73%

Lee et al, Lee et al, AJOG 2015AJOG 2015

Miniarc Miniarc MonarcMonarc

112112113113

1212

92%92%94% 94%

ResultsResults

Cure rate 95% CI Cure rate 95% CIObjective 85 % 81.78-88.22 87% 83.78-90.22Subjective 84% 80.69-87.31 85% 81.58-88.42Composite 84.5% 81.24-87.76 86% 81.68-89.32

SISSISN= 472N= 472

TOTTOTN= 419N= 419

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 rateSimilar for both proceduresSimilar for both procedures

Operating timeOperating timeSignificantly shorter for SIS vs TOTSignificantly shorter for SIS vs TOT

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 the SIS seem to be as effective as standard TOT slings for the treatment of primary SUI treatment of primary SUI