Hysterectomy or uphold uterine conservation in women with apical prolapse: A parallel cohort study of 12 months.

Abstract

Objective: To compare objective and subjective cure rates between Uphold and vaginal hysterectomy. Method(s):Women with symptomatic uterine descent referred for vaginal prolapse surgery were included. Women who chose UpholdTMwere required to have an endometrial assessment. 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 qualityof-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 sidedaof 0.05. Allowing for attrition rate of 15%, we proposedto recruit a total of 114 subjects for the trial. Outcomes were compared with Pearson chi2test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriate. Result(s): We performed 50 VH from August 2011 and November 2013 and 51 Upholds from August 2011 to June 2016, a long recruitment period for Uphold as it coincided with transvaginal mesh FDA notification. Six women from the VH group were lost to follow-up (12%) and 8 from the Uphold (16%). There was balanced demographics and POP-Q measurements between groups. The incidence of stage 2 prolapse in any compartment at 12 months was 48.8%in VH and 33.3% in Uphold. The composite cure rate at 12 months was 79.55% in VH and 72.09% in Uphold. PGI-I was not different between the groups. 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=0.1223), 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 6 grade 3, one mesh exposure requiring excision(2AT2S1), 5 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). There was one repeat surgery in the VH group having a repeat anterior repair and mid-urethral sling. Conclusion(s): Uphold uterine suspension and repair and VH, vault suspension and repair appear to have equivalent objective and subjective cure at 12 months with no significant difference in surgical complications. There was a 2% surgery rate for mesh exposure in the Uphold group which occurred prior to adoption of the transverse incision technique. There was a trend to more re-operation for stress urinary incontinence in the Uphold group. Longer-term follow-up is anticipated.