UOG Journal Club: April 2014 Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial K. SVABIK, A. MARTAN, J. MASATA, R. EL-HADDAD and P. HUBKA Volume 43, Issue 4, Date: April 2014, pages Journal Club slides prepared by Dr Tommaso Bignardi (UOG Editor for Trainees)

Background The use of vaginal mesh for prolapse surgery may reduce recurrence rates. However, to justify potential complications associated with mesh use, it seems necessary to identify women at high risk of prolapse recurrence. In women with a levator avulsion injury the risk of prolapse recurrence is three-to-four times higher than in those without. Levator avulsion and levator hiatal size may be used for identifying patients at high risk for failed prolapse surgery.

Objective: To compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator avulsion Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Post- hysterectomy patients with at least two-compartment prolapse (apical/vault compartment - stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)) Symptoms of prolapse Requesting pelvic floor reconstructive surgery Complete unilateral or bilateral avulsion injury Inclusion criteria Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Patients with prolapse but uterus in place No evidence of levator ani avulsion Patients not requesting pelvic floor surgery Exclusion criteria Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

POP-Q examination 4D ultrasonography with acquisition of volume datasets at rest, during pelvic floor muscle contraction (PFMC) and on maximal Valsalva Validated questionnaires Pre- and postoperative assessment Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Palpation 4D tomographic ultrasound during maximal pelvic floor muscle contraction (PFMC): * levator–urethra gap measurement in three axial slices Volume offline analysis: * levator ani hiatal dimensions on Valsalva - minimal hiatal dimensions in the axial plane Diagnosis of avulsion injury Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Follow up at 3 months and 1 year Primary outcome measure: Anatomical failure based on clinical and translabial ultrasound assessment (defined as Ba, C or Bp at the hymen or below, or a bladder descent to 10 mm or more below the lower margin of the symphysis on Valsalva) Secondary outcome measure: Continence status assessment based on a clinical stress test and subjective evaluation of continence, sexual function and prolapse symptoms (questionnaires) Outcome measures

Patients with vaginal vault prolapse (n = 142) Excluded (n = 72) - Did not meet inclusion criteria for avulsion (n = 70) - Did not agree to undergo surgery (n = 2) SSF (n = 34) Randomized (n = 70) Prolift Total (n = 36) Excluded (n = 0) Treatment failure (n = 0) Excluded (n = 0) Treatment failure (n = 3) 3-month follow-up Follow-up (n = 36) Analyzed (n = 36) (Excluded from analysis, n = 0) Follow-up (n = 31) Analyzed (n = 34) – LFCF analysis (Excluded from analysis, n = 0) 1-year follow-up

SSFProliftP*RR(95% CI) Failure: clinical22 (64.7)1 (2.8)< (3.3–163.5) Failure: ultrasound21 (61.8)1 (2.8)< (3.2–156.4) Incontinence †10 (29.4)16 (44.4) (0.35–1.25 Prolift and SSF data are given as n (%). *Pearson’s chi-square test. †Based on ICIQ-SF score Results: Relative risk (RR) at 1-year follow-up in women with levator avulsion undergoing surgery for post-hysterectomy vaginal vault prolapse, according to intervention; vaginal mesh repair (Prolift Total) or sacrospinous fixation (SSF) Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

SSF (n=34)Prolift (n=36)tP* POP-Q: Aa-0.9 (1.15)-2.4 (0.64) < POP-Q: Ba -0.1 (1.68)-2.4 (0.64) < POP-Q: C -3.2 (3.56)-6.2 (1.29) < POP-Q: Ap -1.8 (1.30)-2.3 (0.71) POP-Q: Bp -1.4 (1.93)-2.3 (0.71) Total vaginal length (cm) 7.1 (1.07)7.4 (1.07) Genital hiatus diameter (cm) 3.5 (0.78)3.3 (0.63) Perineal body length (cm) 4.8 (0.94)4.6 (0.84) Hiatal area on Valsalva (cm²)‡ 37.0 (14.24)29.6 (7.44) Bladder neck descenton Valsalva (cm)§ 0.0 (0.76)-1.2 (0.74)-6.415< Bladder descent on Valsalva (cm)¶ 1.2 (1.11)-1.1 (0.72)−10.365< PISQ-12 score 35.6 (5.07)32.6 (6.26) ̶ 0.194† Prolift and SSF data are given as mean (SD). *Two-sample t-test unless otherwise stated. †Mann–Whitney U-test. ‡Area of levator ani hiatus. §Distance between urethrovesical junction and inferior margin of symphysis pubis. ¶Distance between lowest point of bladder and inferior margin of symphysis pubis (negative values means better support, being above inferior margin of symphysis, positive values meaning below inferior margin of symphysis). POP-Q, Pelvic Organ Prolapse Quantification system. PISQ-12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire. Results: Comparison of clinical (POP-Q) and ultrasound results at 1-year follow-up

Results: Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014 The 1-year postoperative pelvic organ prolapse distress inventory (POPDI) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group (Mann–Whitney U-test, P=0.16) At the 1-year follow-up, there were 16 (44%) patients rated as being stress incontinent in the Prolift group, compared with 10 (29%) in the SSF group (Chi-square P=0.19). In analyzing ‘de novo’ incontinence there were 13 patients in the Prolift group and three patients in SSF group (chi-square, P=0.023).

This trial confirms previous retrospective data showing high recurrence rates after native tissue repair. Despite highly significant difference in anatomical failure rates, no difference in subjective outcomes were found (may be due to a lack of power). Discussion Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

First prospective, randomized study to adopt the 4D ultrasound diagnosis of levator avulsion as an entry criterion Strengths of the study Weaknesses Prolift Total mesh recently removed from the market (can the conclusions apply to other meshes currently available?) Follow-up period of 1 year may be too short Lack of blinding during postoperative assessment Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Conclusions SSF (vaginal sacrospinous colpopexy) in patients with prolapse after hysterectomy and avulsion levator injury has a higher anatomical failure rate compared with the Prolift Total procedure at 1-year follow-up. Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014

Discussion points How can we identify patients at high risk of prolapse recurrence after reconstructive surgery? Should we routinely evaluate levator ani avulsion in women undergoing POP surgery? Which outcome measures should be chosen in POP surgery trials (objective vs subjective)? Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized control trial Svabik et al., UOG 2014