Current trend in anti-incontinence surgery

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Current trend in anti-incontinence surgery

吳銘斌醫師 (Ming-Ping Wu, M.D., Ph.D.) 奇美醫院婦產部婦女泌尿暨骨盆醫學科主任

台北醫學大學醫學院婦產學科副教授成功大學醫學院臨床醫學所博士

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Anti-incontinence surgery

 Bladder buttress operation: Kelly plication

 Needle suspension

 without cystoscopy: Pereyra

 without cystoscopy: Stamey

 Retropubic urethropexy (RPU):

 Marshall-Marchetti-Kranz procedure (MMK);

 Burch colposuspension

 Traditional sling procedures

 Minimally invasive suburethral sling (MISS)

 Tension-free midurethral sling (MUS)

 Periurethral injection

 Artificial urinary sphincter (AUS)

(3)

Kelly plication

Tradition bladder-neck sling

1st generation: Retro-pubic (RP) TVT, SPARC, IVS

2nd generation: Trans-obturator (TO) TVT-O, Monarc

The evolution of anti-incontinence surgeries

3rd generation: Single-incision TVT-secure, MiniArc

IVS: intravaginal sling

TVT: tension-free vaginal tape TVT-O: tension-free vaginal tape -obturator

SPARC: suprapubic arc

Endoscopic bladder neck suspension (EBNS) Retropubic urethropexy: MMK, Burch

Laparoscopic Burch colposuspension

(4)

anti-incontinence surgery

Retropubic urethropexy (RPU)

traditional sling Minimally invasive synthetic suburethral sling (MISS)

(5)

 Stress urinary incontinency (SUI) is a prevalent disease,

 esp. in women of older age,

 with a life long risk of 11% to receive surgery.

 Inpatient Expenditures by Admissions files of the National Health Insurance Research Database (NHIRD): 1996-2005

 A descriptive study to analyze the

 The changing trend of different surgical types

 The characteristics of patients, e.g. age

 Surgeons’ specialties

 The accreditation and ownership of the hospitals

Wu MP 2008 Int Urogyn J

(6)

ICD9 Operation 健保手術計價碼 59.3 Plication of urethra-vesical junction

e.g. Kelly-Kennedy operation

78029B 78037B 59.4 Suprapubic sling operation

e.g. Goebel-Frangenheim-Stoeck suspension

77029B

59.5 (RPU*)

Retropubic urethral suspension

e.g. Marshall-Marchetti-Kranz (MMK) operation; Burch procedure;

78017B MMK 78030B Burch 59.6 Paraurethral suspension

e.g. Pereyra suspension

78028B (?) TA- 78029B (?) TV- 59.71 Levator ani. muscle suspension

59.72 Injection of implant into urethral and/or bladder neck e.g. Collagen implant

78029B (?) TV- 59.79

(MUS*)

repair of stress incontinence NOS (APUS) (TVTs)(TOTs)

77029B APUS

*RPU: retropubic urethropexy; MUS: midurethral sling

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Table 1 Surgical types categorized by chronology

Surgery (ICD-9-CM code)

Year Total RPU Sling MUS Kelly Needle LS Injection ICD-9 (59.5) (59.4) (59.79) (59.3) (59.6) (59.71) (59.72)

n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) 17532 7610 2645 4196 900 1165 853 163

(100) (43.41) (15.09) (23.93) (5.13) (6.64) (4.87) (0.93)

1996 770 281 82 84 95 196 32 0

1997 948 332 81 168 91 200 76 0

1998 1362 732 105 294 68 100 63 0

1999 1618 786 143 375 105 97 112 0

2000 1710 713 239 461 85 102 110 0

2001 2164 914 413 490 78 146 123 0

2002 2308 974 558 450 106 120 100 0

2003 1959 850 395 451 71 79 87 26

2004 2227 1035 322 604 99 54 66 47

2005 2466 993 307 819 102 71 84 90

.

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The trend of different surgical

0 200 400 600 800 1000 1200

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 year n

RPU 59.5 Sling 59.4 TVTs 59.79 Kelly 59.3 Needle 59.6 59.71

Injection 59.72

The changing trend of different surgical types

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Results-I: Changing trend of overall and different surgical types

 There a total of 17,532 female inpatients

 uprising trend: annual growth rate of 22.03%

 retropubic urethropexy (RPU) 43.41%,

 the most frequently used

 midurethral sling (MUS) 23.93%

 traditional sling 15.09%, etc.

 the vicissitude of the different surgical modalities

 RPU remained steady,

 MUS grew fastest

 20.50% from 2002 to 2005

 traditional sling decreased Wu MP 2008 Int Urogyn J

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Table 2 Surgical types categorized by patients’ age

Surgery

Age Total RPU Sling MUS Kelly Needle LS Injection n n (%) n (%) n (%) n (%) n (%) n (%) n (%) Total 17532 7610 2645 4196 900 1165 853 163

<30 (0.80) (27.86) (8.57) (23.57) (7.14) (9.29) (3.57) (20.0) 30-34 (2.37) (46.75) (11.57) (23.13) (6.02) (7.71) (3.86) (0.96) 35-39 (7.33) (49.11) (12.37) (22.49) (3.58) (7.08) (4.59) (0.78) 40-44 (16.43) (52.10) (14.13) (19.47) (3.96) (6.56) (3.37) (0.42) 45-49 (20.19) (48.84) (14.89) (21.24) (3.39) (7.20) (4.10) (0.34) 50-54 (14.13) (45.54) (14.49) (25.23) (3.43) (6.30) (4.40) (0.61) 55-59 (9.50) (38.20) (17.30) (26.19) (5.47) (6.67) (5.77) (0.42) 60-64 (9.79) (37.97) (15.03) (26.91) (6.70) (6.87) (5.82) (0.70) 65-69 (8.87) (32.09) (17.36) (28.42) (8.55) (6.69) (5.59) (1.29)

≧70 (10.59) (32.36) (17.07) (26.93) (8.67) (5.17) (7.49) (2.32)

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Table 3 Surgical types categorized by surgeons’ specialty

Surgery

Variable Total RPU Sling MUS Kelly Needle LS Injection n n (%) n (%) n (%) n (%) n (%) n (%) n (%) Total 17532 7610 2645 4196 900 1165 853 163 Specialty

Gynecology 13736 6495 1899 3263 884 888 306 1 (78.35) (47.28) (13.82) (23.76) (6.44) (6.46) (2.23) (0.01) Urology 3690 1086 733 905 6 266 540 154

(21.05) (29.43) (19.86) (24.53) (0.16) (7.21) (14.63) (4.17)

Others 106 29 13 28 10 11 7 8

(0.60) (27.36) (12.26) (26.42) (9.43) (10.38) (6.6) (7.55)

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Results-II:

 Surgeries performed by

 gynecologists (78.35%)

 urologists (21.05%).

 RPU was the most commonly used procedure

 gynecologists (47.28 %)

 urologists (29.43 %)

 MUS was almost equally adopted by

 gynecologists (23.76%)

 urologists (24.53%)

 Kelly operation

 more commonly used by gynecologists

 Traditional sling

 more popularly used among urologists

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Table 4 Surgical types categorized by hospital accreditation

Surgery

Variable Total RPU Sling MUS Kelly Needle LS Injection n n (%) n (%) n (%) n (%) n (%) n (%) n (%)

Total 17532 7610 2645 4196 900 1165 853 163 Accreditation level

Medical center 11441 4727 1577 3371 570 544 539 113 (65.27) (41.32) (13.78) (29.46) (4.98) (4.75) (4.71) (0.99) Regional hospital 4887 2400 884 667 234 458 196 48

(27.88) (49.11) (18.09) (13.65) (4.79) (9.37) (4.01) (0.98) Local hospital 1202 483 183 157 96 163 118 2

(6.86) (40.18) (15.22) (13.06) (7.99) (13.56) (9.82) (0.17)

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 The increasing number of the total annual anti- incontinence surgeries

 popularity of in medical professionals

 general awareness of the importance of female SUI

 MUS has potentially revolutionized the practice of anti- incontinence surgery

 Rapidest annual growth rate

 RPU remained steady, while traditional sling decreased.

 The difference surgical preference among surgeons of different specialties

 implies the diversity of training.

 The important of education program to help women, esp. elderly, to seek medical treatment

Discussion:

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 Department of Health. Hospital Episode Statistics. Department of Health [online] 2006 URL:http://www.hesonline.nhs.uk

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Open retropubic colposuspension-1

• Cochrane Library 2009 Issue 4

 46 trials, 4738 women.

 Overall cure rates were 68.9% to 88.0%

 lower failure rates compared with conservative treatment (two small studies) .

 lower failure rates compared to anticholinergic treatment.

 a lower failure rate for subjective cure than after anterior colporrhaphy (six trials).

 maintained over time

 RR of failure 0.51; 95% CI 0.34 to 0.76 before the first year,

 RR 0.43; 95% CI 0.32 to 0.57 at one to five years,

 RR 0.49; 95% CI 0.32 to 0.75 in periods beyond 5 years.

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Open retropubic colposuspension-2

 In comparison with needle suspensions

 a lower failure in the first (RR 0.66; 95% CI 0.42 to 1.03),

 after the first year (RR 0.48; 95% CI 0.33 to 0.71),

 beyond five years (RR 0.32; 95% CI 15 to 0.71).

 in comparison with suburethral slings (12 trials)

 no sig. difference in failure rates in all time periods

 open and laparoscopic retropubic

 Patient-reported failure rates in short, medium and long- term follow-up showed: no sig. difference

 but with wide confidence intervals.

 less common after Burch than after the MMK procedure

 (RR 0.38 95% CI 0.18 to 0.76) (2 trials)

 at one to five year follow-up

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Open retropubic colposuspension

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Open retropubic colposuspension-3

 In general, the evidence available does not show a higher morbidity or complication rate with open

retropubic colposuspension, compared to the other open surgical techniques,

 although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures.

(20)

• Open retropubic colposuspension : conclusions

 open retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term.

 overall continence rate: within the first year 85 to 90%.

after five years 70%.

 Newer minimal access procedures like TVT look

promising in comparison with open colposuspension

 but their long-term performance is not known

 closer monitoring of its adverse event profile must be done.

 LSC colposuspension should allow speedier recovery

but its relative safety and effectiveness is not known yet.

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Laparoscopic colposuspension-

(suture vs mesh & staples)

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Laparoscopic colposuspension-

(suture)

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Laparoscopic colposuspension-

(mesh & staples)

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Laparoscopic colposuspension-1

 Cochraen Library 2010 Issue 2

 LSC vs open (10 trials)

 Sub. cure seemed similar, in the short and medium- term follow up,

 poorer results on obj. outcomes (some evidence) .

 fewer perioperative complications,

 less post-op pain

 shorter hospital stay

 however, more costly

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Laparoscopic colposuspension-2

 LSC vs Minimally invasive synthetic suburethral sling (MISS) (8 trials).

 No sig. differences in short and long term sub. cure rates

 Obj. cure rates at 18 months favoured MISS.

 No sig. differences for post-op voiding dysfunction and perioperative complications.

 LSC had a sig. longer operation time and hospital stay.

 2 vs 1 suture (1 trial)

 Sig. higher subj. and obj. one-year cure rates three studies compared

 LSC sutures vs mesh & staples (3 trials)

 A trend towards favouring the use of sutures

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Laparoscopic colposuspension:

conclusions

 LSC as good as open at post-op two years.

 MISS appear to offer even greater benefits,

 better objective outcomes in the short term

 similar subjective outcomes in the longer term.

 If LSC is performed,

 Use of two paravaginal sutures appears to be the most effective method.

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Minimally invasive synthetic suburethral sling-1 (MISS vs traditional sling)

 Cochrane Library 2010 Issue 1

 62 trials, 7101 women,

 The quality of evidence was moderate for most trials.

 MISS as effective as traditional suburethral slings

 RR 1.03, 95% CI 0.94 to 1.13

 with shorter operating time

 less post-operative voiding dysfunction

 Less de novo urgency symptoms.

(28)

Minimally invasive synthetic suburethral sling-2 (MISS vs open RPU)

 MISS as effective as open RPU

 Subj. cure rate: similar

 at 12 mon RR 0.96, 95% CI 0.90 to 1.03;

 at 5 years RR 0.91, 95% CI 0.74 to 1.12.

 with fewer perioperative complications,

 less postoperative voiding dysfunction,

 shorter operative time and hospital stay

 Sig. more bladder perforations

 (6% vs1%, RR 4.24, 95% CI 1.71 to 10.52).

(29)

Minimally invasive synthetic suburethral sling-3 (MISS vs LSC RPU)

 MISS vs LSC RPU:

 conflicting in the short term

 obj. RR 1.15, (95% CI 1.06 to 1.24);

 subj. RR 1.11, (95% CI 0.99 to 1.24).

 less de novo urgency and urgency incontinence,

 shorter operating time,

 Shorter hospital stay

 Shorter time to return to daily activities.

(30)

Minimally invasive synthetic suburethral sling-4 MISS (Retropubic)

 retropubic bottom-to-top route was more effective than top-to-bottom route

 RR 1.10, 95% CI 1.01 to 1.20; RR 1.06, 95% CI 1.01 to 1.11

 Sig, less voiding dysfunction,

 Less bladder perforations

 Less tape erosions.

 Monofilament vs multifilament tapes

 sig. higher obj. cure rates (RR 1.15, 95% CI 1.02 to 1.30)

 fewer tape erosions (1.3% versus 6% RR 0.25, 95% CI 0.06 to 1.00).

(31)

Minimally invasive synthetic suburethral sling-5 TO vs RP

 transobturator vs retropubic route

 less favourable in obj. cure rate (84% versus 88%; RR 0.96, 95% CI 0.93 to 0.99;

 17 trials, n = 2434

 no difference in subj. cure rates.

 less voiding dysfunction, blood loss,

 less bladder perforation (0.3% versus 5.5%, RR 0.14, 95%

CI 0.07 to 0.26)

 shorter operating time

(32)

Minimally invasive synthetic suburethral sling:

Conclusion

 MISS are as effective as traditional suburethral slings, open retropubic colposuspension and laparoscopic colposuspension in the short term

 but with less postoperative complications.

 Obj. cure rates are higher with retropubic tapes than with obturator tapes

 but retropubic tapes attract more complications.

 Most of the trials had short term follow up and the quality of the evidence was variable.

(33)

Comparison of tension-free vaginal tape (TVT) and transobturator tape (TOT)-1

 Cheng-Yu Long, Chun-Shuo Hsu, Ming-Ping Wu, Cheng-Min Liu, Tsu-Nai Wang and Eing-Mei Tsaia,

 A meta-analysis, in the

 TOT (vs TVT)

 short-term obj. cure rate was borderline worse

 [odds ratio (OR) 0.62; 95% (CI) 0.37–1.00; P=0.05].

 TVT (vs TOT)

 sig. more bladder perforation (OR 12.23; 95% CI 2.86–52.34)

 sig. less groin/thigh pain (OR 0.32; 95% CI 0.11–0.92; P=0.022).

Long 2009 Curr Opin

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Comparison of tension-free vaginal tape (TVT) and transobturator tape (TOT)-2

 TVT vs TOT

 Slightly more postoperative urinary retention

 (OR 1.6; 95% CI 0.90–3.12; P¼ 0.06).

 More obstructive,

 evidenced by ultrasonographic and urodynamic findings.

 TVT vs TOT comparable in

 vaginal erosion (OR 0.34; 95% CI 0.09–1.33),

 de-novo urgency (OR 1.21; 95% CI 0.52–2.79)

 urinary tract infection (OR 0.88; 95% CI 0.56–1.38)

 Changes in sexual function need further investigation

 not been well studied for either sling procedure.

Long 2009 Curr Opin

(35)

 565/ 597 (94.6%) completed the 12-month assessment.

 Success rate: RP vs TO:

 no sig. differences

 Obj. success: 80.8% 77.7% (3.0 %-point difference; 95% [CI], - 3.6 to 9.6).

 Subj. success: 62.2% and 55.8%, (6.4 %-point difference; 95%

CI, -1.6 to 14.3).

 voiding dysfunction

 2.7 vs 0% (P=0.004)

 neurologic symptoms

 4.0% and 9.4% (P=0.01).

 postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.

 no sig. differences

2010 NEJM

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2010 NEJM

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Treatment failure

2010 NEJM

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1st

2nd

3rd

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Single incision sling

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Mount Rushmore

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THANK YOU

Mount Rushmore