K. SVABIK, A. MARTAN, J. MASATA, R. EL-HADDAD and P. HUBKA ABSTRACT

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1 Ultrasound Obstet Gynecol 2014; 43: Published online 11 March 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI: /uog 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 controlled trial K. SVABIK, A. MARTAN, J. MASATA, R. EL-HADDAD and P. HUBKA Department of Obstetrics and Gynecology, 1 st Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic KEYWORDS: 4D ultrasound; levator avulsion; mesh; Prolift Total; sacrospinous vaginal colpopexy; SSF; ultrasound assessment; vaginal prolapse surgery; vaginal sacrospinous fixation ABSTRACT Objective To compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion. Methods This was a single-center, randomized interventional trial, of two standard surgical procedures for post-hysterectomy vaginal vault prolapse: Prolift Total vs unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair (sacrospinous fixation, SSF), during the period from 2008 to Entry criteria included at least two-compartment prolapse, as well as complete unilateral or bilateral levator ani avulsion injury. The primary outcome was anatomical failure based on clinical and ultrasound assessment. Failure was defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below, and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva maneuver. Secondary outcomes were evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires. Results During the study period, 142 patients who were post-hysterectomy underwent surgery for prolapse in our unit; 72 of these were diagnosed with an avulsion injury and were offered participation in the study. Seventy patients were randomized into two groups: 36 in the Prolift group and 34 in the SSF group. On clinical examination at 1-year follow-up, we observed one (3%) case of anatomical failure in the Prolift group and 22 (65%) in the SSF group (P < 0.001). Using ultrasound criteria, there was one (2.8%) failure in the Prolift group compared with 21 (61.8%) in the SSF group (P < 0.001). The postoperative POPDI (Pelvic Organ Prolapse Distress Inventory) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group (P = 0.16). Conclusion In patients with prolapse after hysterectomy and levator ani avulsion injury, SSF has a higher anatomical failure rate than does the Prolift Total procedure at 1-year follow-up. Copyright 2014 ISUOG. Published by John Wiley & Sons Ltd. INTRODUCTION The lifetime risk for pelvic floor surgery for prolapse is likely to be between 10% and 20%, and a large number of patients require repeat surgery for recurrence 1.There is some evidence that anchored vaginal mesh may reduce recurrence rates 2. However, mesh use is associated with significant and, in some cases, atypical complications 3. To justify the use of mesh and potential complications associated with doing so, it seems necessary to identify those at high risk of prolapse recurrence 4. There is evidence indicating that levator ani avulsion injury ( avulsion ) is closely associated with prolapse. Avulsion is a detachment of the puborectalis/pubovisceralis muscle from its insertion on the inferior pubic ramus, which is clearly associated with vaginal childbirth 5,6. This leads over time to enlargement of the levator hiatus ( ballooning ) 7. Women with levator avulsion defects are around twice as likely to show pelvic organ prolapse of stage II or higher as are those without such defects. The association seems strongest for Correspondence to: Dr K. Svabik, Department of Obstetrics and Gynecology, 1 st Faculty of Medicine, Charles University in Prague and General University Hospital, Apolinarska 18, Prague 2, , Czech Republic ( kamil@svabik.eu) Accepted: 18 December 2013 Copyright 2014 ISUOG. Published by John Wiley & Sons Ltd. RANDOMIZED CONTROLLED TRIAL

2 366 Svabik et al. cystocele (relative risk (RR), 2.3; 95% CI, ) and uterine prolapse (RR, 4.0; 95%, CI ) 8. Symptoms of prolapse are significantly associated with avulsion injury in patients after hysterectomy 9,10. Furthermore, the relative risk of recurrence after anterior colporrhaphy in patients with levator avulsion injury is three-to-four times higher than it is in those without 11,12, and it seems that levator avulsion and levator hiatal size may be used for identifying patients at high risk for failed prolapse surgery 13,14. Our aim was to compare, with a 1-year follow-up examination in patients with post-hysterectomy prolapse and levator avulsion, the efficacy of two standard surgical procedures for vaginal vault prolapse: Prolift Total vs sacrospinous vaginal colpopexy (the Amreich Richter procedure) with native tissue vaginal repair (sacrospinous fixation, SSF). We limited this trial to patients who had been diagnosed with levator avulsion in order to maximize power and the potential benefit of mesh use. We considered it potentially unethical to offer mesh to all patients with post-hysterectomy prolapse due to concerns about mesh complications, and since there is some evidence that reduction in recurrence due to mesh may be limited largely to patients with levator avulsion 15. METHODS This was a single-center, randomized controlled trial of two standard surgical procedures for vaginal vault prolapse: Prolift Total (Prolift Total, Gynecare, Ethicon, Sommerville, NJ, USA) vs sacrospinous vaginal colpopexy (the Amreich Richter procedure) with native tissue vaginal (anterior and posterior) repair (SSF) 16. Both procedures are designed to treat vault prolapse vaginally, one with mesh implantation and the other with vaginal repairs and apical fixation to the sacrospinous ligament, usually on the right All patients attended our urogynecological unit (Ob/Gyn Department of General University Hospital in Prague) during the period from 2008 to Eligible for inclusion were: posthysterectomy patients with at least two-compartment prolapse (with affected apical/vault compartment, stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)), suffering from symptoms of prolapse, requesting pelvic floor reconstructive surgery, and diagnosed with a complete unilateral or bilateral avulsion injury. Excluded were: patients with prolapse and uterus in place, those without levator ani avulsion and those not requesting pelvic floor surgery. Patients underwent identical pre- and postoperative assessment procedures, including POP-Q examination, 4D ultrasonography with acquisition of volume datasets at rest, during pelvic floor muscle contraction (PFMC), and on maximum Valsalva maneuver, which were archived on a server, and validated questionnaires. The study was approved by the local ethics committee (as part of national grant application NT ) and all subjects gave written informed consent to participate. At the time of enrolment (usually 2 3 months prior to surgery), to fulfill the main inclusion criterion, preoperative levator assessment and avulsion diagnosis was performed. Patients were examined clinically and by translabial 3D/4D ultrasound by one of two physicians (K.S. and J.M.), both experienced in pelvic floor ultrasound examination, using a Voluson 730 Expert/E8 system (GE Medical Systems, Zipf, Austria) equipped with a 8 4-MHz curved array volume transducer. The POP-Q classification for prolapse was used, and diagnosis of avulsion injury was performed by palpation and confirmed by 3D tomographic ultrasound imaging during maximum PFMC, using the levator urethra gap measurement in three axial slices (one at the plane of minimal hiatal dimensions and two parallel slices, with 2.5-mm slice intervals, above this reference plane) In addition, volume datasets were acquired with the patient in a supine position and with empty bladder, at rest, on maximum Valsalva maneuver and during PFMC 23, for later offline analysis using the proprietary software GE Kretz 4D View v. 9.0 (GE Medical Systems). This analysis included measurement of levator ani hiatal dimensions on Valsalva maneuver in the axial plane of minimal hiatal dimensions 7. All offline analyses were performed by one of two doctors (R.E. and P.H.), who were semi-blinded: they were not aware of the POP-Q score or the surgical procedure, but in most cases postoperatively, the implants were visible on ultrasound. The randomization process was carried out by computer, using patient hospitalization numbers, the night before surgery. Patients were informed about their allocation after the procedure. Both procedures were performed by an experienced surgeon (K.S. or J.M., both of whom are familiar with both procedures), with the patient under general anesthesia. For the Prolift Total procedure, the Prolift Total kit was used and the mesh placed according to the recommended technique 19. After hydrodissection, a midline anterior colpotomy with fascia dissection was performed, and the bladder was dissected laterally to the pelvic side wall. The posterior vaginal wall was dissected between apex and perineum, and sacrospinous ligaments were verified. The Prolift guides were inserted (two pairs through obturator membrane and one pair through sacrospinous ligament via ischiorectalis fossa). The mesh was inserted, spread anteriorly from the bladder neck, and sutured to the vaginal apex using Vicryl plus 2.0 (Ethicon, Sommerville, NJ, USA). Posteriorly, the mesh was attached to the introitus. The vaginal wall was sutured with running Monocryl 2.0 suture (Ethicon). The last step of the procedure involved stretching the mesh and removing the guides. There was no fascial plication in the Prolift group. Dissection for the SSF procedure was performed in a similar manner but without dissection of fascia. In all cases in the SSF group we performed conventional anterior vaginal repair and posterior high levatorplasty. The anterior vaginal repair (fascial plication of the entire

3 Prolapse in patients with levator ani defect 367 anterior wall starting at the level of the bladder neck) was done using Vicryl plus 2.0 stitches (Ethicon). For the posterior high levatorplasty, Vicryl plus 1.0 stitches (Ethicon) were used. The SSF procedure was performed unilaterally on the right using two permanent sutures of Nurolon 1.0 (Ethicon) inserted under visual control and attached to the vaginal apex. Patients were followed up at 3 months and at 1 year 24. These postoperative clinical examinations were performed by a single examiner (A.M.), who had not been involved with the surgical procedures and was unaware of a patient s procedure at the start of the assessment, although in some cases group allocation became obvious due to palpable mesh, mesh erosion or visibility of an SSF suture. The follow-up translabial ultrasound examinations were performed by a single examiner (K.S.) after the clinical examination. Anterior vaginal wall descent was assessed in the mid-sagittal plane, at maximum Valsalva maneuver. The inferior margin of the symphysis pubis was used as a reference point, with measurements presented being distances from this reference line, as previously published 25.Tworeference points of the anterior vaginal wall were defined: the bladder neck and the lowermost part of the bladder wall. As in the preoperative examination, volume datasets were stored for later offline analysis by the same two doctors (R.E. and P.H.). At the 3-month follow-up, in cases of urinary stress incontinence we offered patients treatment with a tensionfree vaginal tape-obturator (TVT-O) procedure. In the case of recurrence of prolapse and distressing symptoms which a patient desired to be resolved, we performed reoperation of prolapse (symptomatic prolapse). For evaluation in such cases we used the last failure carried forward method, i.e. in cases which underwent an antiincontinence procedure or reoperation after the 3-month follow-up, we used the data obtained at the 3-month follow-up for evaluation rather than obtaining data at the 1-year follow-up. The primary outcome measure was anatomical failure based on clinical and ultrasound assessment. Failure was defined clinically as Ba, C or Bp at the hymen or below, and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva 26. As secondary outcome measures we used a continence status assessment based on a clinical stress test, performed with the bladder containing ml urine and assessed by ultrasound, and on subjective evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires: ICIQ-SF (International Consultation for Incontinence Questionnaire Short Form), PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire), POPDI, UDI (Urinary Distress Inventory) and CRADI (Colorectal Distress Inventory). The power calculation was based on the two primary outcome measures and available data which led us to expect a failure rate of 60% in the SSF group 8,14.To detect an expected difference of 45% between the groups, with 80% power of the test and with a 5% level of significance, 30 patients were required in each group. Data were analyzed using the software STATISTICA 10 (StatSoft. Inc software, Tulsa, OK, USA). Descriptive analyses are provided. Comparisons between the groups were performed after normality testing by parametric twosample t-test or non-parametric Mann Whitney U-test. Categorical data were analyzed by Pearson s chi-square test or the McNemar test. All tests were performed at the 5% level of significance. RESULTS During the study period, 592 patients underwent surgery for female pelvic organ prolapse in our unit. Of these, 142 had a post-hysterectomy vault prolapse, of whom 72 were diagnosed with an avulsion injury (Figures 1 and 2) 27. These patients were offered participation in the trial, and 70 were randomized into two groups: 36 in the Prolift group and 34 in the SSF group. There were no major complications such as heavy bleeding, bladder or bowel injury in either group and no drop-outs during the 1-year follow-up period. There was no difference between the two groups in demographic parameters or in preoperative POP-Q or ultrasound findings used as outcome measures in this trial (Table 1). At the 3-month follow-up, 11 patients in the Prolift group and three in the SSF group were diagnosed with stress urinary incontinence and scheduled for a TVT-O procedure (chi-square P = 0.02). Three other patients in the SSF group were diagnosed with symptomatic prolapse recurrence and scheduled for repeat surgery; one underwent reoperation with Prolift Total mesh, one with Prolift Anterior mesh and one with Prolift Posterior mesh. No patient in the Prolift group was diagnosed with symptomatic recurrence (chi-square P = 0.06). There was minor mesh exposure at the 3-month followup in the Prolift group in three (8%) cases; two of these were resected during a TVT-O procedure, while the third was asymptomatic and treated conservatively. There was no additional case of protrusion at the 1- year follow-up. There were five (15%) patients with vaginal blood spotting due to granulation tissue in the SSF group, all of whom were treated on an outpatient basis. At the 1-year follow-up, there was one (3%) anatomical failure clinically, i.e. prolapse to the hymen or beyond, in the Prolift group (posterior compartment), compared with 22 (65%) failures in the SSF group (20 affecting anterior, six central and eight posterior compartment) (chi-square P < 0.001, Table 2). In two of the latter cases, the anterior compartment was not affected. Based on POP-Q grade II prolapse criteria, there were six (17%) failures in the Prolift group and 30 (88%) failures in the SSF group (chi-square P < 0.001). According to ultrasound criteria for anterior compartment prolapse recurrence, there was one (3%) failure in the Prolift group compared with 21

4 368 Svabik et al. Figure 1 Ultrasound images (axial plane) in a patient with right-sided levator ani avulsion injury: (a) during contraction, showing urethra levator gap measurement (calipers); and (b) during Valsalva, showing hiatal area measurement (dotted line) and moderate ballooning. Patients with vaginal vault prolapse (n = 142) Enrolment Excluded (n = 72) Did not meet inclusion criteria for avulsion (n = 70) Did not agree to undergo surgery (n = 2) Randomized (n = 70) Prolift Total (n = 36) Allocation SSF (n = 34) Excluded (n = 0) Treatment failure (n = 0) 3-month follow-up Excluded (n = 0) Treatment failure (n = 3) Follow-up (n = 36) Analyzed (n = 36) (Excluded from analysis (n = 0)) 1-year follow-up Follow-up (n = 31) Analyzed (n = 34) LFCF analysis (Excluded from analysis (n = 0)) Figure 2 Participant flow diagram. LFCF, last failure carried forward. (62%) failures in the SSF group (chi-square P < 0.001) (Table 2). At the 1-year follow-up, there were significant differences between the Prolift and SSF groups for all POP-Q parameters except genital hiatal diameter, perineal body length and total vaginal length (Table 3). On translabial ultrasound there was a significantly smaller hiatal area and a lower degree of bladder neck descent and bladder base descent in the Prolift group 11 (Table 3). The 1-year postoperative 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) (Table 4). 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). Sexual activity was not influenced by the type of surgery. There was no difference in PISQ-12 score between groups both before and after surgery (Tables 1 and 3). At the 1-year follow-up there were two patients with dyspareunia in the Prolift group and one in the SSF group.

5 Prolapse in patients with levator ani defect 369 Table 1 Comparison of preoperative demographic, clinical (POP-Q) and ultrasound parameters in women with levator ani avulsion undergoing surgery for post-hysterectomy vaginal vault prolapse, according to intervention: vaginal mesh repair (Prolift Total) or sacrospinous fixation (SSF) Parameter SSF (n = 34) Prolift (n = 36) t P* Age (years) 62.5 (10.85) 63.4 (8.61) Height (cm) (5.81) (6.17) Weight (kg) 74.8 (10.60) 73.1 (9.89) Body mass index (kg/m 2 ) 28.2 (4.18) 27.2 (3.21) Parity 2.2 (0.67) 2.1 (0.83) POP-Q: Aa 0.9 (1.27) 1.3 (1.72) POP-Q: Ba 3.6 (2.45) 4.1 (2.43) POP-Q: C 1.5 (3.86) 2.1 (3.89) POP-Q: Ap 0.7 (1.50) 0.4 (1.76) POP-Q: Bp 2.4 (2.74) 2.4 (2.87) Total vaginal length (cm) 8.0 (0.79) 8.1 (0.91) Genital hiatus diameter (cm) 4.6 (1.07) 4.8 (0.98) Perineal body length (cm) 3.9 (0.98) 3.6 (1.15) Hiatal area on Valsalva (cm 2 ) 43.1 (12.22) 43.5 (12.49) PISQ-12 score 33.1 (6.31) 30.3 (9.52) 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. POP-Q, Pelvic Organ Prolapse Quantification system; PISQ-12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire. Table 2 Relative risk (RR) of surgical failure/incontinence at 1-year follow-up in women with levator ani avulsion undergoing surgery for post-hysterectomy vaginal vault prolapse, according to intervention: vaginal mesh repair (Prolift Total) or sacrospinous fixation (SSF) SSF Prolift P* RR (95% CI) Failure: clinical 22 (64.7) 1 (2.8) < ( ) Failure: ultrasound 21 (61.8) 1 (2.8) < ( ) Incontinence 10 (29.4) 16 (44.4) ( ) Prolift and SSF data are given as n (%). *Pearson s chi-square test. Based on ICIQ-SF score. Table 3 Comparison of clinical (POP-Q) and ultrasound results at 1-year follow-up in women with levator avulsion who had undergone surgery for post-hysterectomy vaginal vault prolapse, according to intervention: vaginal mesh repair (Prolift Total) or sacrospinous fixation (SSF) Parameter SSF (n = 34) Prolift (n = 36) t P* 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 (cm 2 ) 37.0 (14.24) 29.6 (7.44) Bladder neck descent on Valsalva (cm) 0.0 (0.76) 1.2 (0.74) < Bladder descent on Valsalva (cm) 1.2 (1.11) 1.1 (0.72) < PISQ-12 score 35.6 (5.07) 32.6 (6.26) 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 mean better support). POP-Q, Pelvic Organ Prolapse Quantification system. PISQ-12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire. DISCUSSION To the best of our knowledge, this is the first prospective, randomized study of women with vaginal prolapse to adopt the 3D/4D ultrasound diagnosis of levator avulsion as an entry criterion, based on the assumption that avulsion identifies a group of patients at high risk of prolapse recurrence after reconstructive surgery. Female pelvic organ prolapse is a highly heterogeneous condition and the etiology is likely to be multifactorial. There are a number of studies identifying predictors of recurrence, with levator ani avulsion injury being one of the main risk factors for recurrent prolapse after classical native tissue repair 11 13,15. This prospective, randomized, controlled trial confirms previous retrospective data showing high recurrence rates after native tissue

6 370 Svabik et al. Table 4 Distress inventory scores 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) Distress inventory Mean Min Max SD P* Preoperative UDI 0.10 Prolift SSF POPDI 0.96 Prolift SSF CRADI 0.61 Prolift SSF Postoperative (1-year follow-up) UDI 0.66 Prolift SSF POPDI 0.16 Prolift SSF CRADI 0.09 Prolift SSF *Mann Whitney U-test. CRADI, Colorectal Distress Inventory; POPDI, Pelvic Organ Prolapse Distress Inventory; UDI, Urinary Distress Inventory. repair, especially for the anterior compartment. The study of Dietz et al. found a recurrence rate after native tissue repair of 79% at an average follow-up interval of 4.5 years in women with levator avulsion, which is comparable to our finding of 62% failure at 1 year, using identical assessment criteria 11. Comparison of our data with the results of studies assessing similar procedures without levator ani assessment reveals substantial discrepancies. In general, recurrence rates are higher after SSF than after mesh treatment, but the differences between these groups are much smaller in studies not utilizing levator ani assessment 28. A comparison of our data in the SSF group with the results of studies using the same procedure shows our observed failure rate to be much higher. Hefni and El-Toukhy 18 reported only 10% recurrent cystoceles at a median 15-month follow-up. Maher et al. 17,ina randomized trial comparing abdominal sacral colpopexy and vaginal sacrospinous colpopexy (SSF), found at 2-year follow-up that there was no difference in objective cure rates between the groups. The cure rate in the SSF group was 69%. Such discrepancies are likely to be due to our selection of a high-risk group of patients, which apparently increased substantially the power of our study. In another randomized study, comparing mesh and conventional repair in patients with recurrent prolapse, the failure rate at 1-year follow-up was 45% in the conventional repair group and 10% in the mesh group 29. These data are similar to ours, presumably because levator ani defects are more prevalent in patients with recurrent prolapse. As regards mesh-related complications, on the other hand, our results are comparable to data in the literature. The protrusion rate of 8.3% is similar to that reported in other trials 19,30,31. We observed a significantly higher reoperation rate for urinary stress incontinence in the Prolift group, which differs from previously published data 3 but correlates with more recent data 30,32.Thisis consistent with a higher prolapse recurrence rate in the SSF group, which may have resulted in a higher incidence of urethral kinking, masking stress incontinence in those with recurrent cystocele. It has been shown by Eisenberg et al. 33 that avulsion is associated with Green type III cystocele and an increased likelihood of urethral kinking and voiding problems rather than stress incontinence. It is interesting that, despite the highly significant difference in anatomical failure rates, we were unable to show any difference in subjective outcomes using the distress inventory questionnaires. This correlates with many previously published studies 3,11,28, and may be due to lack of power. A post-hoc power calculation based on questionnaire results suggests that, in order to prove the superiority of mesh surgery with questionnaire data as the primary outcome measure, we would have needed 200 patients in each group. This is very likely due to the large variability in assessment of subjective symptoms 34. This observation raises the question as to which outcome measures should be chosen in trials of this kind. Clearly, subjective measures are important, since our ultimate goal is not cosmetic improvement, but improvement of quality of life. However, assuming that one procedure is superior in correcting an anatomical abnormality that is causing significant symptoms (as shown in our study), it may be neither ethical nor economical to require much larger trials for proof of superiority on the basis of inferior outcome measures. Requiring a trial of 400 patients rather than 60 would of course mean that a much larger number of patients would have to undergo an inferior procedure. Several weaknesses of this trial must be acknowledged. The Prolift Total mesh has recently been removed from the market. However, judging from published data it is likely that our conclusions may apply to other type-i polypropylene meshes 15. Furthermore, the follow-up period of our study was 1 year, which may be considered too short, although recent data suggest that the vast majority of prolapse recurrences are evident at the 1-year mark 35. We will, however, continue the follow-up in order to assess long-term outcomes and complications. We are aware that, due to palpable or visible mesh or visibility of SSF sutures, there was a lack of blinding during the assessment in some patients; this is unavoidable in trials of this kind. We tried to minimize any resulting bias by using two objective assessment methods, i.e. the POP-Q and sonographic assessment of prolapse. In conclusion, 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.

7 Prolapse in patients with levator ani defect 371 ACKNOWLEDGMENTS This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic (grant NT ) and by Charles University in Prague (UNCE ). We would like to thank O. Sottner for the randomization process. Disclosure A. M. acts as consultant for Bard, Gynecare, and AMS. REFERENCES 1. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010; 116: Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. New Engl JMed2011; 364: Maher CM, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J 2011; 22: Dietz HP. Mesh in prolapse surgery: an imaging perspective. Ultrasound Obstet Gynecol 2012; 40: Dietz HP, Lanzarone V. 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A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol 2012; 207: 301.e Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 2011; 117: de Landsheere L, Ismail S, Lucot JP, Deken V, Foidart JM, Cosson M. Surgical intervention after transvaginal Prolift mesh repair: retrospective single-center study including 524 patients with 3 years median follow-up. Am J Obstet Gynecol 2012; 206: 83.e Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol 2010; 115: Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013; 4: CD Eisenberg VH, Chantarasorn V, Shek KL, Dietz HP. Does levator ani injury affect cystocele type? Ultrasound Obstet Gynecol 2010; 36: El Haddad R, Svabik K, Masata J, Martan A, Hubka P. Does the grade of vaginal wall prolapse correlate with the Pelvic organ prolapse distress inventory (POPDI) scores? Int Urogynecol J 2012; 23: S43 S Hankins K, Wong V, Dietz HP. The natural history of prolapse recurrence. Int Urogynecol J 2014; DOI /s

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