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 365-371 http://onlinelibrary.wiley.com/doi/10.1002/uog.13305/abstract

1. 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 365-371
Journal Club slides prepared by Dr Tommaso Bignardi
(UOG Editor for Trainees)

2. 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.

3. 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

4. • 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

5. • 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

6. • 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

7. • 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

8. • 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

9. 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

10. SSF Prolift P* RR (95% CI)
Failure: clinical 22 (64.7) 1 (2.8) < 0.001 23.3 (3.3–163.5)
Failure: ultrasound 21 (61.8) 1 (2.8) < 0.001 22.2 (3.2–156.4)
Incontinence † 10 (29.4) 16 (44.4) 0.19 0.66 (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

11. SSF (n=34) Prolift (n=36) t P*
POP-Q: Aa -0.9 (1.15) -2.4 (0.64) -7.019 <0.0001
POP-Q: Ba -0.1 (1.68) -2.4 (0.64) -7.533 <0.0001
POP-Q: C -3.2 (3.56) -6.2 (1.29) -4.618 <0.0001
POP-Q: Ap -1.8 (1.30) -2.3 (0.71) -2.278 0.026
POP-Q: Bp -1.4 (1.93) -2.3 (0.71) -2.839 0.006
Total vaginal length (cm) 7.1 (1.07) 7.4 (1.07) 0.833 0.408
Genital hiatus diameter (cm) 3.5 (0.78) 3.3 (0.63) -0.978 0.331
Perineal body length (cm) 4.8 (0.94) 4.6 (0.84) -1.115 0.269
Hiatal area on Valsalva (cm²)ffi 37.0 (14.24) 29.6 (7.44) -2.682 0.009
Bladder neck descenton Valsalva (cm)§ 0.0 (0.76) -1.2 (0.74) -6.415 <0.0001
Bladder descent on Valsalva (cm)¶ 1.2 (1.11) -1.1 (0.72) −10.365 <0.0001
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.
ffiArea 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

12. 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).

13. • 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

14. • 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

15. 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

16. 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