Status Plus

abstract

33 - 4 YEAR OUTCOMES OF FOLLOW UP OF EXTRAPERITONEAL UTEROSACRAL VAULT SUSPENSION WITH MESH VERSUS SACROCOLPOPEXY FOR TREATMENT OF VAULT PROLAPSE - A RANDOMISED CONTROLLED TRIAL

033

4 YEAR OUTCOMES OF FOLLOW UP OFEXTRAPERITONEAL UTEROSACRAL VAULT SUSPENSION WITH MESH VERSUSSACROCOLPOPEXY FOR TREATMENT OF VAULT PROLAPSE - A RANDOMISEDCONTROLLED TRIAL

L. OW1, Y. N. LIM 2,J. LEE 3, C. J. MURRAY 4, E. A. THOMAS 5,A. LEITCH 6, A. ROSAMILIA 7, P. L. DWYER 8;
1Mercy Hosp., Victoria, Australia, 2MercyHosp. for Women, Heidelberg, Australia, 3Mercy Hosp. forWomen, Melbourne, Australia, 4Urogynaecology, Mercy Hosp.for Women, Melbourne, Australia, 5Urogynaecology, MercyHosp. for Women, Victoria, Australia, 6Deakin Univ., EastBentleigh, Australia, 7Monash Hlth., Monash Univ. &Cabrini Hospita, melbourne, Australia, 8Mercy Hopsital forWomen, Melbourne, Australia.

Introduction: Sacrocolpopexy(SCP) has been shown to be superior to vaginal sacrospinous fixationfor management of vault prolapse. However, in many of these studies,vaginal sacrospinous fixation was performed without meshaugmentation. There remains a paucity of long term data comparingsacrocoplpopexy versus vaginal vault suspension with mesh. We presentthe 4 year follow up of the subjective outcomes of vaginalextraperitoneal uterosacral suspension with mesh (VEULS) versussacrocolpoexy.
Objective: To compare subjective outcomes 4years following extraperitoneal uterosacral vault suspension withmesh versus sacrocolpopexy for treatment of vault prolapse.
Methods:This was a multicentre RCT involving women with post hysterectomyanterior and vault prolapse >=stage 2 POPQ. Exclusion criteriaincluded a past history of urogenital fistula, SCP, VEULS or majormesh complications. All women were invited to return for astandardized questionnaire and ICS POPQ assessment. Women who wereunable to attend were encouraged to return the questionnaires inregards to their symptoms and quality of life (PFDI-20, PFIQ-7,PISQ-12 and VAS). UltraPro (Ethicon, NJ) meshes were used in bothgroups. In the vaginal group, mesh was implanted in overlay fashionwith arms to the paravaginal space anteriorly after fascialplication, and VEULS were performed with two 0 PDS suturesbilaterally. SCP was performed laparoscopically or abdominally atsurgeon’s discretion. We planned to recruit 55 patients in eacharm, allowing for 15% attrition, based on the following assumptions:recurrence rate of 13% for SCP group, a reduction of recurrence rateto 25% for the vaginal group from 45% to obtain a power of 80% with aone-sided α level of 0.05. Outcomes were compared with Pearson χ2test for categorical data and Student t test or Wilcoxonrank-sum for continuous data as appropriate. Objective outcomesincluded POPQ examination and subjective outcomes were recorded at12, 24 and 48 months post-operatively. If they declined a face toface review, they were invited to complete subjective and quality oflife questionnaires.
Results: 82 women were randomisedduring the study period of which 39 received VEULS and 43 receivedSCP. 34 SCP were performed laparoscopically, of which 3 wereconverted to open and 9 were performed open. 49/82 (59.8%) womenreturned for review at 24 months and 25/82 (30.5%) women returned forreview at 48/12. 56/82 (68.3%) returned questionnaires at 24/12 and70/82 (85.4%) at 48/12. Results evaluated by ITT analysis. Table 1shows comparisons of demographics. Table 2 shows the objective andsubjective outcomes. Composite outcomes for success at 12/12 were 41%for VEULS and 65.1% for SCP (OR 2.68, p=0.03) and at 24/12 were 51.6%for VEULS and 61.9% for SCP (p 0.78.) The mesh erosion rates at 12/12(VEULS 2/37(5.4%) vs SCP3/31 (9.7%), p0.65), 24/12 (VEULS 3/32 (9.4%)vs SCP 0/19 (0%),p0.28) and 48/12 ( VEULS 1/13 (7.7%) vs SCP 1/12(8.3%), p1.00) were similar. Subjective outcomes were similar at 24and 48 months. Post-operative POPDI score improved similarly for bothgroups at 12/12, 24/12 and 48/12. The minimally important differenceof at least -21 was reached for both groups.Only 25 patients returnedfor review at 48 months (13 VEULS and 12 SCP) hence the objectiveoutcomes after 48/12 were too low to make meaningful comparison andhence composite outcomes were not calculated at this timepoint.
Conclusions: There was a trend towards less vaginalbulge (p=0.06) with sacrocolpopexy compared to VEULS. Both VEULS andSCP conferred improved the POPDI scores in the medium term with nodifference between the 2 groups. This may be due to insufficientpower of the study or a lack of responsiveness of POPDI.
References:Maher C, Feiner B, Baessler K, Schmid C. Surgical management ofpelvic organ prolapse in women. . Cochrane Database Syst Rev 4.2013.Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, SchluterPJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy forvaginal vault prolapse: a prospective randomized study. Am J ObstetGynecol. 2004;190(1):20-6. Chan SS, Cheung RY, Lai BP, Lee LL, ChoyKW, Chung TK. Responsiveness of the Pelvic Floor Distress Inventoryand Pelvic Floor Impact Questionnaire in women undergoing treatmentfor pelvic floor disorders. Int Urogynecol J. 2013;24(2):213-21.

Table1: Demographics

Variable

VEULS(39/82)

SCP(43/82)

Age,yrsMin,Max

65.3(47/83)

66.5(53,81)

BMI(min,max)

27.8(18.6,34.0)

27.3(18.0,38.3)

Parity

3(0,5)

2(0,9)

PreviousPOP surgery, n(%)

23(59%)

21(51.2%)

Postmenopausal,n (%)

15(48.4%)

21(55.3%)


Table2: Objective and subjective outcomes


Pre-op


12months


p

24months

p


48months


p


VEULS(n=39/39)

SCP(n=43/43)

VEULS(n=37/39)

SCP(32/43)


VEULS(n= 32/3)

SCP(n=19/43)


VEULS(n= 13/39)

SCP(n=12/43)


Ba

1.0(-2.0, 8.0

1.0(-2.0, 8.0)

-1.0(-3.0, 1.0)

-1.5(-3.0, 2.0)

0.47

-1.0(-3.0,2.0)

-1.5(-3.0,2.0)

0.41

-1.5(-3.0,2.0)

-2.0(-3.0,1.0)

0.91

C

0.0(-3.0, 10.0)

0.0(-3.0, 10.0)

-6.0(-10,1.0)

-8.0(-10.0,2.0)

0.005

-6.0(-8.0,0.0)

-7.0(-10.0,2.0)

0.15

-6.0(-8.0,-2.0)

-7.0(-9.0,-1.0)

0.18

Bp

0.0(-3.0, 8.0)

0.0(-3.0, 8.0)

-2.0(-3.0,0.0)

-2.0(-3.0,2.0)

0.21

-2.0(-3.0,0.0)

-2.0(-3.0,1.0)

0.35

-2.0(-3.0,0.0)

-2.0(-3.0,-1.0)

0.52

TVL

9.0(7.0, 11.0

9.0(7.0, 12.0)

8.0(4.0,10.0)

9.0(7.0,11.0)

0.05

8.0(4.0,10.0)

9.0(5.0,10.0)

0.31

8.0(7.0,10.0)

9.0(5.0,10.0)

0.3

POPDIscore

43.2(24.0)8.3, 100

42.6(27.3) 0.0, 100

14.5(19.0) 0.0, 58.3

12.7(18.3)0.0, 87.5

0.65

11.0(19.1) 0.0, 66.7

12.8(20.8)0.0, 100

0.63

3.5(4.7) 0.0, 16.0

3.3(4.1) 0.0, 14.0

0.66

CRADIscore

28.9(22.7) 3.1, 93.8

25.3(23.4) 0.0, 87.5

16.5(18.0) 0.0, 62.5

18.9(19.7) 0.0, 78.1

0.68

12.1(16.9) 0.0, 71.9

20.7(24.8)0.0, 96.8

0.23

13.7(17.5) 0.0, 71.9

12.9(16.3) 0.0, 62.5

0.83

UDIscore

32.5(27.7) 0.0, 100.0

35.0(28.7) 0.0, 87.5

20.9(24.6)0.0, 83.3

16.4(21.4)0.0, 100

0.58

13.5(19.8) 0.0, 58.3

19.3(22.5) 0.0, 100

0.14

21.4(21.8) 0.0, 79.2

18.9(22.5) 0.0, 75.0

0.34

Bothersomevaginal bulge

32/39(82.1%)

34/43(79.1%)

2/34(5.9%)

3/34

1.00

4/23(17.4%)

4/32(12.5%)

0.71

9/34(26.5%)

3/35(8.6%)

0.06

SexuallyActive

15/31(48.4%)

21/38(55.3%)

17/32(53.1%)

13/32(40.6%)

0.45

12/23(52.2%)

19/32(59.4%)

0.78

9/34(26.5%)

7/35(8.6%)

0.58

PISQ

18.0(32.4) 6.1, 44.0

22.0,(32.0) 7.0, 45.0

17.0(32.8) 6.6, 41.0

13.0(34.9) 4.9, 42.0

0.51

12.0(31.8) 11.5, 42.0

19.0(33.7) 9.0, 47.0

0.75

9.0(31.7) 8.4, 39.0

7.0(36.3) 5.0, 41.0

0.14