High levator myorraphy versus uterosacral ligament suspension for vaginal vault fixation: a prospective, randomized study

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1 Int Urogynecol J (2010) 21: DOI /s x ORIGINAL ARTICLE High levator myorraphy versus uterosacral ligament suspension for vaginal vault fixation: a prospective, randomized study Franca Natale & Chiara La Penna & Anna Padoa & Massimo Agostini & Massimo Panei & Mauro Cervigni Received: 10 July 2009 / Accepted: 19 November 2009 / Published online: 26 February 2010 # The International Urogynecological Association 2010 Abstract Introduction and hypothesis Our study compared high levator myorrhaphy (HLM) and uterosacral ligament suspension (USLS) for vaginal apex fixation from both an anatomical and functional point of view, and assessed the impact of surgery on quality of life (QoL) and sexuality. Methods Two hundred twenty-nine patients with symptomatic stage 2 apical prolapse were randomized to USLS or HLM. Those patients who also needed cystocele repair additionally underwent an anterior prosthetic reinforcement. We defined as cure no prolapse of stage 2 or greater in any compartments according to the POP-Q system. Results Correction of apical prolapse was observed in 96.6% of the HLM group and 98.3% of the USLS group. However, a persistent anterior wall prolapse occurred in 29.2% of the HLM group and in 35.4% of the USLS group. Both groups reported improvement in storage, voiding, and prolapse-related symptoms. Urodynamics of patients in the HLM group showed post-operative reduction in detrusor pressure at maximum flow and an increase in maximum flow. Both groups saw similar improvement in QoL. We did not encounter any serious side effects, except for nine cases of intraoperative ureteral occlusion following USLS. Conclusion This study demonstrates similar efficacy of HLM and USLS for vaginal apex suspension; however, USLS has a higher incidence of complications involving the upper urinary tract. F. Natale (*) : C. La Penna : A. Padoa : M. Agostini : M. Panei : M. Cervigni Department of Urogynecology, S. Carlo-IDI Hospital, Via Aurelia 275, Rome, RM, Italy f.natale@idi.it Keywords High levator myorrhaphy. POP surgery. Prospective randomized study. Uterosacral ligament suspension. Vaginal apex fixation. Vaginal vault prolapse Introduction Pelvic organ prolapse (POP) includes various degrees of anatomical defects, ranging from mild descensus of the uterus and vaginal wall to total vaginal eversion. The alterations in urinary, anorectal, and sexual function which often arise in POP have a great impact on women s quality of life (QoL) and need to be clinically addressed. The prevalence of POP is more than 30% in gynecologic patients aged years [1]. The annual incidence of cystocele, rectocele, and uterine prolapse is 9.3, 5.7, and 1.3 cases per 100 women-years, respectively [2]. The percentage of women needing POP surgery increases gradually with age and reaches 7% in the eighth decade of life [3]. Vaginal apex fixation is a mandatory step in POP surgery. In the presence of incorrect uterine or vaginal vault suspension, intra-abdominal pressure exerts excessive strain on the vaginal wall and this predisposes to prolapse recurrence. Vaginal vault prolapse is caused by damage to the cardinal and uterosacral ligaments (DeLancey s level one) [4]. Discrete tears can be seen in the uterosacral ligaments of women with high-grade POP, which explain the frequent occurrence of enterocele and vault prolapse [5]. Central defects are seldom isolated, and often coexist with anterior and/or posterior wall defects, as described by Richter, who reported a combination of pelvic floor defects in 72% of POP patients [6]. Likewise, DeLancey reported the presence of multiple pelvic floor defects in % of patients [4].

2 516 Int Urogynecol J (2010) 21: More than 40 different procedures for uterine or vaginal vault suspension have been described in the literature, including abdominal, vaginal, and laparoscopic procedures. Different studies have variously found the recurrence rate of vaginal vault prolapse following surgical correction of apical defects to be between 3% and 10%, depending on the technique used [7]. For some time we have been developing an original technique for vaginal apical suspension high levator myorrhaphy (HLM). This is distinguished from high midline levator myorrhaphy proposed by Lemack et al. [8], from which it derives, in that we use just one suture whereas he uses two per side. This suture is more medial and thus further from the ureter, to reduce the risk of damage to the ureter. Also, the use of a single suture for vaginal vault suspension makes this procedure fast and easy to perform compared to the "double stitch" procedure or to more complex and lengthy techniques such as SSF. We find the learning curve for HLM to be relatively short making it easy for a pelvic surgeon to carry out. We wished to compare HLM to a well-established technique and chose one of the more popular transvaginal techniques for vaginal vault suspension without mesh the uterosacral ligament suspension (USLS) calculating that its similarities to HLM would render the comparison meaningful. Thus, the aim of this prospective, randomized study was to evaluate and compare the anatomical outcome of HLM and USLS on symptomatic stage 2 apical prolapse. We had, as a secondary objective, the evaluation of the incidence and type of complications for each procedure and the impact of surgery on urinary and anorectal function, sexuality, and QoL. Material and methods Patients with symptomatic stage 2 apical prolapse were included in our study. We excluded patients with concomitant stress urinary incontinence as well as any who had undergone previous hysterectomy, POP, or SUI surgery in order to avoid any interference this might give to the interpretation of the results. All patients underwent pre-operative gynecological work-up, which included: History Pelvic examination (the severity of POP was assessed using the Pelvic Organ Prolapse Quantification (POP-Q) staging system) with patients in supine position [9] Conventional urodynamic study performed twice, in the second case with a reduction in prolapse using vaginal packing to diagnose occult stress urinary incontinence Validated questionnaires including: Prolapse Quality of Life (P-QoL) Questionnaire [10] A short form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [11] Wexner score for constipation [12]. Methods, definitions and units conform to the standards recommended by the International Continence Society [13]. All patients underwent vaginal hysterectomy. For the correction of anterior vaginal defect (point Ba 1 cm, meaning 113 patients in the HLM group and 106 patients in the USLS group) tension-free cystocele repair was performed. This technique involves the use of a polypropylene mesh positioned under the bladder without anchoring sutures but with two wings inserted bilaterally into the paraurethral space [14]. No colporrhaphy is performed before mesh placement. A few patients had posterior colpocele (point Bp>+1 cm) and these underwent plication of the prerectal fascia with a continuous vicryl-0 suture. For vaginal suspension, patients were randomly assigned, by use of a computer-generated list, to one of two groups: group 1 underwent HLM and group 2 underwent USLS. All patients provided their informed consent to participate in our study. The study was approved by the Ethical Committee of our Institution. Surgical techniques High levator myorrhaphy Midline posterior colpotomy extending from the vault to the perineum is performed. The prerectal fascia is dissected separating the vaginal wall from the underlying rectum. This dissection is extended to the ischiorectal fossa with the aid of Briesky retractors, until the sheath of the puborectalis muscle becomes visible laterally. Using a single vicryl-2 suture, the right apex of the vaginal cuff is attached laterally to the ispilateral puborectalis sheath, 1 cm in front of the ischial spine. The same suture then makes a loose stitch through the proximal end of the prerectal fascia. This procedure is then continued on the left side using the same suture. The two ends of the suture are then tied, bringing together the two puborectalis sheaths [15]. Uterosacral ligament suspension Using a vicryl-1 suture on each side, the vaginal cuff is suspended from the remaining part of each uterosacral

3 Int Urogynecol J (2010) 21: ligament at or 1 cm above the ischial spine, being careful to incorporate the rectovaginal and the pubocervical fascia into the suture at the apex. This suture also incorporates both anterior and posterior vaginal epithelium. In all cases this technique was performed intraperitoneally. Cystoscopic assessment of ureteral patency was made after completion of each procedure. All patients were operated on by one of three different primary surgeons. The senior author (MC) was the primary surgeon in 175 of the cases and the first assistant in the others. Post-operative work-up was performed at 6 months, at 1 year, and then annually. Each visit included a pelvic examination and questionnaires. Conventional urodynamic studies were performed at 1 year. We defined cure as no prolapse stage 2 or greater in any compartments, according to the POP-Q system. Statistical analysis Assuming a two-sided hypothesis test with a 5% type 1 error and 80% power, we estimated that a sample size of 110 patients in each study arm was necessary to detect a 15% difference in vaginal vault prolapse between the two techniques. In order to allow for a 10% drop-out rate, we sought to enroll 120 subjects in each study arm. The Chi-square test was used for comparison of categorical variables between the pre- and post-operative period, the paired t test for continuous parametric variables, and the Mann Whitney test for continuous non-parametric variables. We considered p<0.05 to be statistically significant. No financial assistance was received from any company in the design or execution of this study. Results Between September 2005 and December 2007, a total of 240 patients were enrolled. Of these, 229 patients were found to be eligible for the study: 116 were randomized to the HLM group and 113 to the USLS group. Preoperatively, no significant differences were found between the groups in terms of demographic data (Table 1), degree of POP, or urodynamic findings. The hospital stay was 4 8 days in the HLM group (mean 4.2) and 4 10 days for the USLS group (mean 5.2) with p= Spontaneous voiding resumed at 2 5 days (mean 3.3) for the HLM group and 2 8 days (mean 4.5) for the USLS group (p=0.44). There were very few intraoperative complications in either group: we had three cases of pararectal hematoma in the HLM group, and one case of rectal injury in the USLS group. All patients completed the stated procedures. On cystoscopic evaluation, no intraoperative ureteral obstruction was observed in the HLM group. In the USLS group, intraoperative cystoscopy revealed left ureteral occlusion in nine cases (7.9%) and right ureteral obstruction in one patient. In all ten patients, the USLS suture was removed and replaced in a more medial position on that side. No further intervention was required. All patients completed the 1-year follow-up. Postoperatively, we observed mesh erosion in the anterior vaginal wall in 12 patients (10.3%) in the HLM group and in 16 patients (14.2%) in the USLS group. This was treated with removal of the exposed mesh and resuturing of the anterior vaginal wall. In the HLM group we observed de novo buttock pain that resolved spontaneously in 8 weeks. Only one case of buttock pain was observed in the USLS group. On post-operative anatomical assessment, patients in both groups showed a significant correction of vaginal prolapse at point C: HLM (110 patients 94.8%, p=0.001) and USLS (108 patients 95.6%, p=0.004). In the HLM group we observed an anatomical correction of point Ba in 82 patients 70.7% of sample (p=0.01) and of point Bp in 104 patients 89.7% (p=0.009; Table 2). In the USLS group we obtained a statistically significant correction of vaginal descensus at point Ba (73 patients 69.1%, p= 0.002) and at point Bp (102 patients 90.3%, p=0.002; Table 3). There were no statistically significant differences between the results of the two groups in post-operative anatomical results. Evaluation of post-operative total vaginal length showed a mean of 7.9 cm in the HLM group and 9.1 cm in the USLS group (p=0.03). Despite this, no significant difference was observed between groups in the incidence of post-operative dyspareunia (p=0.08). Furthermore, patients in the HLM group reported significant post-operative improvement in voiding and storage LUTS, in symptoms associated with POP and also post-micturition symptoms. Following surgery, patients in the USLS group reported significantly fewer voiding and post-micturition symptoms and fewer symptoms associated with POP (Table 4). Urodynamic studies of the HLM group patients showed both a significant reduction in detrusor pressure at maximum flow (Pdet at Qmax) (mean pre 32.4 cm H 2 O vs. mean post 22.1 cm H 2 O p=0.01) and a significant increase in maximum flow (mean pre 10.9 vs. mean post 15.2, p=0.02). No significant changes were noted in urodynamic parameters in the USLS group (Table 5). In the HLM group, P-QoL Questionnaire indicated a statistically significant improvement in all domains except Personal Relationship and Emotions. In the USLS group P-QoL Questionnaire showed a significant improvement in

4 518 Int Urogynecol J (2010) 21: Table 1 Demographic data: comparison between group HLM group USLS group p value Patients Age years (mean 65.2) years (mean 63.7) 0.34 Parity 0 4 (median 2) 0 8 (median 2) 0.85 Menopause 97 patients (83.6%) 88 patients (77.9%) 0.07 BMI kg/m 2 (mean 26.8) kg/m 2 (mean 24.9) 0.26 No. sexually active patients 57 (49.1%) 59 (52.2%) 0.43 all domains except General Health Perception and Sleep. No statistically significant differences were found between the two groups (Table 6). The comparison of the pre- and post-operative PISQ-12 scores showed no impact of surgery on sexuality in the HLM group (mean pre 23 vs. mean post 38 p=0.96) or in the USLS group (mean pre 21 vs. mean post 35 p=0.48). The Wexner score for constipation revealed no impact on anorectal function in either group (p=0.66 in the HLM group and 0.39 in the USLS group). No statistically significant differences were found between post-operative data of the two groups in symptoms, urodynamic data, or prolapse degree. Regarding de novo symptoms, an increased incidence of post-operative de novo stress (11 patients 9.7% vs. seven patients 6.1%) and urge incontinence (ten patients 8.8% vs. one patient 0.9%) was observed in the USLS group as compared to the HLM group. De novo dyspareunia was observed in seven patients (6.1%) in the HLM group and in nine patients (7.6%) in the USLS group. Of these, four patients in the HLM group and five patients in the USLS group showed vaginal erosion, and after its removal dyspareunia disappeared. Discussion Several surgical techniques have been described for vaginal apex suspension using a vaginal approach. Among these, one of the more used techniques is the suspension of the vaginal cuff to the sacrospinous ligament, which stretches from the ischial spine to the sacrum. With this procedure a success rate of 85 90% is reported [16, 17]. However, this surgical approach may be complicated by nerve injury, by hemorrhage from injury to the pudendal artery, or by recurrent cystocele of up to 20% due to the anatomic distortion of the vaginal axis [7]. Uterosacral ligament fixation was first suggested by Miller in 1927 as an anchoring point to suspend the vault of the vagina [18]. In 1957, McCall described passing a suture from one side of the vaginal cuff and uterosacral ligament through the peritoneum to the other side, effectively closing the cul-de-sac [19]. Some authors have attempted to improve the surgical outcome by attaching the cuff to the uterosacral ligament, at or above the ischial spines. Surgeons differ in the number of sutures placed on each side, type of suture used, location of rectovaginal and anterior vault suture placement, depth of suture placement, location of suture in relation to pelvic anatomy and ischial spines, timing of intraoperative cystoscopy, closure of the cul-de-sac, and technique of cuff closure [20]. This technique can be performed by a transperitoneal or extraperitoneal approach. The intraperitoneal approach has been reported by a number of authors to give good results, with a success rate varying from 87% [21] to 100% [22]. Compared with other apical suspension techniques, this procedure is more anatomical and hence least likely to predispose to future defects in the anterior or posterior vaginal wall or compromise vaginal function [23]. Despite the advantages of transperitoneal USLS, major operative and post-operative complications have been reported with this technique, in particular, a % Table 2 Pre- and post-operative POP-Q measurements in the HLM group Point Ba Point C Point Bp Pre-op # (%) Post-op # (%) Pre-op # (%) Post-op # (%) Pre-op # (%) Post-op # (%) Stage (29.3) 0 67 (57.8) 0 80 (68.9) Stage I 3 (2.6) 48 (41.4) 0 43 (37.1) 52 (44.8) 24 (20.7) Stage II 21 (18.1) 25 (21.6) 33 (28.4) 3 (2.6) 59 (50.9) 10 (8.6) Stage III 86 (74.1) 9 (7.6) 62 (53.4) 2 (1.7) 5 (4.3) 2 (1.7) Stage IV 6 (5.2) 0 21 (18.1) 1 (0.9) 0 0

5 Int Urogynecol J (2010) 21: Table 3 Pre- and post-operative POP-Q measurements in the USLS group Point Ba Point C Point Bp Pre-op # (%) Post-op # (%) Pre-op # (%) Post-op # (%) Pre-op # (%) Post-op # (%) Stage (36.3) 0 68 (60.2) 0 69 (61.1) Stage I 5 (4.4) 32 (28.3) 0 40 (35.4) 59 (52.2) 33 (29.2) Stage II 13 (13.3) 38 (33.6) 35 (30.9) 4 (3.5) 44 (38.9) 10 (8.8) Stage III 86 (76.1) 2 (1.8) 63 (55.8) 1 (0.9) 10 (8.8) 1 (0.9) Stage IV 7 (6.2) 0 15 (13.3) incidence of ureteral kinking or damage [5, 24]. Barber et al. reported two cases of severe ureteral damage that required re-implantation of the ureter following USLS [24]. If the peritoneal cavity cannot be entered due to adhesions from previous pelvic surgery, or the USL cannot be palpated because of extensive trauma or attenuation, it could be difficult to use USL for suspension [19]. Recently, an extraperitoneal approach has been described using the uterosacral ligaments to reattach the vaginal vault. The ischial spine is palpated extraperitoneally, and a delayed absorbable suture is placed through the ligament bilaterally, and suspended from the vaginal epithelium [25]. This approach has been shown to provide a good success rate with an objective success rate regarding the vaginal cuff of 95.4% and a global anatomical success rate of 85.5% with a 2-year follow-up. The main advantage of this technique is the avoidance of entering the peritoneal cavity thus reducing the risk of intraperitoneal organ and ureteral injury [26]. Our study compared transperitoneal USLS with HLM a different vaginal procedure for vault suspension to evaluate whether it is able to replicate the good results of USLS but with fewer complications. HLM involves anchoring the vaginal vault to the puborectalis at the level of the ischial spine using one single suture, taking care to avoid narrowing of the vagina. Such narrowing seems to occur when the two sides of the muscle are brought excessively close together, consequently making it the main cause for dyspareunia. The results of this prospective, randomized study show significant correction of apical defects following surgery (96.7% correction in the HLM group vs. 98.3% in the USLS group). Likewise, anatomical correction of posterior wall defects was good (point Bp 1 cm in 91.4% of the HLM group and 96.4% of the USLS group). A persistent anterior wall prolapse (point Ba according to POP-Q) occurred in 29.2% of the HLM group and in 35.4% of the USLS group, but the difference between the two groups was not statistically significant (p=1). This occurrence may be explained by our choice of mesh repair. In our technique the mesh is placed between the anterior vaginal wall and the bladder without lateral anchorage, so the mesh reinforces only the central part of the pubocervical fascia but it does not help reconstruct the lateral anchoring of the vagina (DeLancey s level 2). A better lateral anchorage would be provided by the new Table 4 Pre- and post-operative symptoms in the HLM and in the USLS groups HLM group USLS group Pre-op # (%) Post-op # (%) p Pre-op # (%) Post-op # (%) p Increased daytime frequency 49 (42.2) 29 (25) (48.7) 43 (38.1) 0.92 Urgency 87 (75.0) 39 (33.6) (46.9) 41 (36.3) 0.76 Urge urinary incontinence 70 (60.3) 32 (27.6) (43.4) 39 (34.5) 0.36 Nocturia 39 (33.6) 26 (22.4) (29.2) 18 (15.9) 0.12 Hesitancy 52 (44.8) 9 (7.6) (65.5) 15 (13.3) Slow stream 45 (38.8) 31 (26.7) (62.8) 26 (23.1) Feeling of incomplete emptying 51 (43.9) 4 (3.4) (54.9) 13 (11.5) Buttock pain 16 (13.8) 18 (15.5) (18.6) 16 (14.2) 0.77 Dyspareunia 19 (16.4) 23 (19.8) 1 22 (19.5) 27 (23.9) 0.49 Constipation 25 (21.6) 29 (25) (16.8) 21 (18.6) 1 Heaviness 87 (75.0) 7 (6.1) (78.8) 11 (9.7) 0.001

6 520 Int Urogynecol J (2010) 21: Table 5 Pre- and post-op urodynamic parameters in the HLM and in the USLS groups HLM group USLS group Pre-op Post-op p Pre-op Post-op p First desire to void ml, mean ml, mean ml, mean ml, mean (SD 77.2) (SD 65.2) (SD 56.0) (SD 69.3) Maximum bladder ml, mean ml, mean ml, mean ml, mean 0.14 capacity (SD 78.9) (SD 58.6) (SD 86.3) (SD 70.8) Detrusor overactivity 37 pats (31.9%) 29 pats (25.0%) pats (41.6%) 55 pats (48.7%) 0.12 Detrusor pressure at 4 64 cm H 2 O, mean cm H 2 O, mean 0.01* cm H 2 O mean 7 60 cm H 2 O, mean 0.18 maximum flow 31.8 (SD 13.2) 23.1 (SD 14.4) 35.8 (SD 11.8) 28.6 (SD 12.9) Maximum flow 2 25 ml/s, mean 10.9 (SD 6.4) 4 27 ml/s, mean 15.2 (SD 6.2) 0.02* 4-37 ml/s, mean 12.2 (SD 7.6) 1 40 ml/s, mean 13.7 (SD 8.4) 0.77 transobturator meshes: these have excellent lateral anchorage achieved through the two pairs of lateral arms that pass through the arcus tendineous of the levator ani thus guaranteeing the first and second levels of suspension. We had no intraoperative complications in the HLM group whereas ten patients in the USLS group had an intraoperative ureteral occlusion that resolved with suture removal. This complication has been reported with a similar incidence in other studies: in a recent review on this subject, Gustillo-Ashby et al. reported an incidence rate of complications affecting the ureter in approximately 6% of cases [27]. These complications are due to the proximity of the ureter to the anterior margin of the USL. Thus, if our objective is to reduce complications affecting the ureter, the optimum point in which to fix the suture (from which the vaginal cuff is suspended) is at the farthest point from the ureter. In normal anatomy this is at the level of the sacral portion of the uterosacral ligament: the ureter is 4.1 cm (±0.6 cm) from the sacrum, 2.3 cm (±0.9 cm) from the ischial spine, and 0.9 cm (±0.4 cm) from the cervix. Moreover, this sacral part of the USL is especially rich in collagen, thus rendering it a stronger, more stable support for the vaginal vault [28]. Fixing in this way will reduce the likelihood of complications but will not guarantee against them. In fact, prolapse involves changes in anatomical relationships thus rendering less certain any a priori assumptions about optimum distance. However, if the suspending sutures are positioned too close to the sacrum, the sacral plexus trunk of S1 S4 could be entrapped causing buttock pain and numbness radiating to the posterior thigh and poplitea fossa [29]. It is possible to test for ureteral obstruction and thus reduce the risk of permanent injury to the ureter by carrying out intraoperative cystoscopy with intravenous indigo carmine dye after the placement of the suture [26]. Cystoscopy, however, should be repeated after the sutures have been tied so as to reveal any kinking caused by pulling on the sutures. No complications affecting the ureter were noted in the HLM group, which suggests that the suspending sutures are placed more distally to the ureter, compared to USLS, and so in a safer position. The other complication reported in the literature is a bowel obstruction in 0.3% of cases [30]. In our series we had no bowel complication in either group. Subjective outcome showed a significant post-operative improvement in both groups. Regarding de novo symptoms, the unkinking of the urethra in POP surgery can sometimes unmask a stress incontinence which effectively appears as de novo [31]. Table 6 Comparison between post-operative scores of P-QoL in HLM and ULSL groups P-QoL domains HLM group (mean) ULSL group (mean) p General health perceptions Prolapse impact Role limitations Physical limitations Social limitations Personal relationships Emotions Sleep/energy Severity measures

7 Int Urogynecol J (2010) 21: Given that there are not yet any evidence-based techniques to determine when unkinking might be accompanied by post-operative SUI, we preferred to test for SUI clinically and urodynamically at follow-up. Additionally, our series shows a higher than expected incidence of de novo urge incontinence following USLS. A possible explanation could be found in the higher incidence of pre-op urodynamic detrusor overactivity in the USLS group, which may indicate a potential urge incontinence masked by prolapse. No negative impact was noted on either sexual or anorectal function following surgery, as demonstrated by the unchanged PISQ-12 score and Wexner score before and after surgery in both groups, and as also demonstrated by the fact that the comparative post-op scores of the two groups were not statistically different. In conclusion, this prospective, randomized study demonstrates the equal efficacy of two techniques for vaginal apex suspension as regards anatomical and functional outcomes, as well as the impact of these procedures on QoL. A higher incidence of complications in the upper urinary tract resulted from the USLS procedure. In order to identify and avoid ureteral injury during USLS, advanced surgical training and an intimate understanding of pelvic anatomy are required. A factor we believe should be taken into account when choosing the most appropriate technique for vaginal vault suspension. Conflicts of interest The authors have no consultancy, stock ownership or other equity interest, patent received or pending, nor do they have any commercial relationship which might in any way be considered related to this article. References 1. 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