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243 - HYSTERECTOMY OR UPHOLD UTERINE CONSERVATION IN WOMEN WITH APICAL PROLAPSE: S PARALLEL COHORT STUDY OF 6 MONTHS

243

HYSTERECTOMY OR UPHOLD UTERINE CONSERVATION IN WOMEN WITH APICAL PROLAPSE: S PARALLEL COHORT STUDY OF 6 MONTHS

R. YOUNG1, A. LEITCH 1, L. OW 2, J. MELENDEZ 1, G. EDWARDS 1, F. CHAO 1, Y. N. LIM 3, J. K. LEE 4, A. ROSAMILIA 5, P. L. DWYER 6;
1Monash Hlth., EAST BENTLEIGH, Australia, 2Mercy Hosp., Victoria, Australia, 3Mercy Hosp. for Women, Heidelberg, Australia, 4Mercy Hosp. for Women, Armadale, Australia, 5Monash Hlth., Monash Univ. & Cabrini Hospita, melbourne, Australia, 6Mercy Hopsital for Women, Melbourne, Australia.

Introduction: There is increasing recognition that women may wish to avoid hysterectomy at the time of POP repairs. Despite a reduced apical recurrence rate favoring vaginal hysterectomy(VH) at 12 months, a recent RCT comparing sacrospinous hysteropexy with VH showed no difference in functional outcomes1. Systematic reviews had demonstrated a reduction in recurrence rate of the anterior compartment when synthetic mesh is utilized for POP repairs.2 Preliminary results of UpholdTM, a minimally invasive transvaginal approach to treat anterior/apical prolapse, showed a low complication rate and low recurrence rate at 12 months. 3
Objective: To compare objective and subjective cure rates in Uphold and vaginal hysterectomy.
Methods: This study was planned and designed as a multicentre RCT but due to poor recruitment it was changed to patient preference study. Women with symptomatic uterine descent referred for vaginal prolapse surgery were included. Women who chose UpholdTM were required to have an endometrial assessment. UpholdTM was initially performed as a vertical incision however changed to a horizontal incision with plication and single layer closure with IV antibiotics and gentamicin irrigation, concomitant prolapse surgery was at the discretion of the surgeon. VH was performed in standard fashion, together with concomitant modified McCall Culdoplasty or high intra-peritoneal uterosacral suspension. Routine clinic follow up was scheduled at 6 weeks, 6 & 12 months, involving a clinical review, examination with symptom & quality of life questionnaires. Primary outcome was incidence of stage 2 prolapse in any compartment and a composite cure of no leading edge beyond the hymen, absence of bulge symptoms on questionnaire and no retreatment. Secondary outcomes were quality-of-life measures (PFDI-20, PFIQ-7, PISQ, Patient Global impression of improvement, EQ5D and a health score) Assuming a recurrence rate of 30% for VH, with a power of 80%, a sample size of 49 each arm would be required to detect a clinical difference of 20% with UpholdTM, using a one sided a of 0.05. Allowing for attrition rate of 15%, we propose to recruit a total of 114 subjects for the trial. Outcomes were compared with Pearson chi2 test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriate.
Results: We performed 50 VH and 52 Upholds from August 2011 to June 2016, a long recruitment period for Uphold as it coincided with transvaginal mesh FDA notification. Table 1 showed balanced demographics and POP-Q measurements between groups. Table 2 displays the prolapse outcomes at 6 months. The incidence of stage 2 prolapse in any compartment at 6 months was 64% in VH and 46% in Uphold. The composite cure rate was 82% in VH and 86.5% in Uphold. PGI-I was not different between the groups with 44/47 in VH and 38/40 in Uphold reporting very much better or much better. There was significant change in POPDI-6 (p<0.0001), CRAD-8 (p=0.0004), UDI-6 (p<0.0001), total PFDI 20 (p<0.0001) and PFIQ7 scores (p =0.0004) between the two time points but not between two comparators. There was no significant difference in surgical complication (p=0.0797), assessed using Clavien-Dindo classification. In the Uphold group, there were 9 grade 1 for prolonged catheterization, 3 grade 2 (2x UTI’s and 1 mesh exposure that resolved with oestrogen) and 4 grade 3, one mesh exposure requiring excision (2AT2S1), 1 vaginal adhesion separated without anaesthetic and 2 repeat surgery for stress urinary incontinence. In the vaginal hysterectomy group, there was 1 grade 1 for prolonged catheterization, 7 grade 2 (1x vault infection requiring readmission for IVAB, 1 vault haematoma with readmission, 1 PE, 4 UTI’s).
Conclusions: Uphold and VH appear to have equivalent objective and subjective cure at 6 months with no significant difference in surgical complications. Longer-term follow-up is anticipated.
References:

  1. Int Urogynecol J Pelvic Floor Dysfunct 2010; 21: 209-216
  2. Cochrane Database of Systematic Reviews 2016, Issue 2. Art. No.: CD012079. DOI: 10.1002/14651858.CD012079
  3. Urogynecol J. 2015 Dec;26(12):1803-7.

 

Table 1. Baseline demographics

 

VH n=50

Uphold n=52

P Value

Age M± SD

61.7±9.2

63.6±9

0.2981

Menopause n (%)

42 (84%)

48 (92.3%)

0.1930

Parity median (IQR)

3(2, 3.25)

2 (2,3)

0.105

BMI M± SD

25.8± 6

26.3±3.8

0.6736

Stage 2 POP n(%)

23 (46%)

27 (51.9%)

0.5497

Stage 3 POP

25 (50%)

23 (44.2%)

0.5595

Stage 4 POP

1 (2%)

1 (1.9%)

1

PFDI-20

107.4± 55.7

104.9± 60.2

0.8344

PFIQ

27.1± 28.7

37.7± 45.2

0.5137

PISQ

28.3± 8.9

30.9± 8

0.2719

EQ5D

6.4± 2.5

6.8± 1.7

0.5177

 

Table 2. 6 month outcomes

 

VH n=50

Uphold n=52

P value

PGI-I median(range)

1(1-3)

1(1-3)

0.3745

PFDI-20

41.65±  32.5

46.4±40.7

0.5492

PISQ

34.9 ±4.9

33.6

0.5221

PFIQ

11.5 ±27.5

12.6±24

0.8416

EQ5D

6.1 ±0.4

5.8 ±0.3

0.5355

Stage2in any compartments(%)

32 (64%)

24 (46%)

0.0702

Apex Stage ≥ 2

0

0

1

Anterior stage ≥ 2

27(54%)

21(40.4%)

0.1684

Posterior Stage ≥ 2

10 (20%)

8 (15.4%)

0.5410

Incidence of SUI

12 (24%)

18/46 (39%)

0.1101

Composite cure

41 (82%)

45 (86.5%)

0.5287