Studio prospettico randomizzato di confronto fra due tecniche per la sospensione dell'apice vaginale: miorrafia alta degli elevatori vs colposospensione ai legamenti utero sacrali alti: valutazione anatomo-clinica e l'impatto sulla qualità di vita

Hypothesis / aims of study The primary objective of this prospective randomized study is to evaluate the anatomical efficacy and the safety of two different transvaginal techniques for suspension of the superior vaginal segment in patients with Pelvic Organ Prolapse (POP) > stage 2: High Levator Myorraphy (HLM) (1) and Uterosacral Vaginal Vault Suspension (UVVS) (2). The secondary objective is to define the impact of these procedures on anorectal function, sexuality and Quality of Life (QoL) Study design, materials and methods Between September 2005 and December 2006, 116 female patients were enrolled. The pre-operative work-up included: history, POP-Q score, Q-Tip test, conventional urodynamic studies and questionnaires (King’s Health Questionnaire, Wexner score for constipation, and a Sexuality score). The patients were randomized into two groups (computer generated randomization list): in the first group we used the HLM procedure for vaginal vault suspension ; in the second group the UVVS was performed. All the patients underwent correction of cystocele with a Polypropylene mesh applied “tension-free” and vaginal hysterectomy. The results were analyzed using: T-test, McNemar Chi-squared test and Mann-Whitney U test. We considered p<0.05 as statistically significant. Results The groups were matched for age, parity and menopausal status. The demographic characteristics of both groups are reported in Table 1 Table 1 – Demographic characteristics of both groups HLM UVVS P* Patients (#) 58 58 0.18 Age 50-78 years (mean 66.3), 45-78 years (mean 60.2), 0.25 Parity 0-4 (median 2) 1-8 (median 2) 0.97 Menopause 54 patients (93.1%) 48 patients (82.8%) 0.08 Body Mass Index 20.31-35.56 (mean 26.2) 20-34.25 (mean 25.98) 0.49 * Mann Whitney U test There were no significant pre-operative differences between the two groups regarding storage and voiding symptoms, urodynamic parameters and grade of prolapse. Pre and post-operative symptoms are reported in Table 2 for HLM and UVVS groups Table 2 – Post-opeartive symptoms in both groups LM # (%) UVVS # (%) P* Increased daytime frequency 13 (22.4%) 23 (39.7%) 0.18 Urgency 21 (36.2%) 25 (43.1%) 0.57 Urge urinary incontinence 18 (31.1%) 25 (43.1%) 0.38 Nocturia 12 (20.7%) 17 (12.1%) 0.57 Hesitancy 4 (6.9%) 6 (10.3%) 0.61 Slow stream 17 (29.3%) 14 (24.1%) 0.75 Feeling of incomplete emptying 3 (5.2%) 9 (15.5%) 0.37 Dyspareunia 13 (22.4%) 16 (27.6%) 0.13 Constipation 15 (25.9%) 13 (22.4%) 1 Heaviness 4 (6.9%) 5 (8.6%) 0.61 * McNemar Chi-square test In Table 3 anatomical results for HLM and UVVS groups are reported. Table 3 – Post-operative anatomical results for both groups LM UVVS P* Point Aa > 2 33 (56.9%) 32 (55.2%) 1 Point Ba > 2 20 (34.5%) 23 (39.7%) 1 Point C > 2 2 (3.4%) 1 (1.7%) 0.47 Point Bp > 2 5 (8.6%) 2 (3.5%) 1 Total Vaginal Length Mean 7.2 cm Mean 8.9 cm 0.04 * McNemar Chi-square test Post operative Urodymanics data are reported in Table 4 Table 4 – Post-operative urodynamics data in both groups HLM UVVS P First desire to void 46-232 ml (mean 120.1, SD 72.21) 30-347 ml (mean 136.69, SD 71.91) 0.29* Maximum Bladder capacity 250-644 ml (mean 378.4, SD 78.87) 191-481 ml (mean 360.76, SD 72.31) 0.33* Pressure at Maximum flow 12-60 cmH20 (mean 25.2, SD 13.22) 69.60 cmH20 (mean 25.24, SD 811-92) 0.99* Maximum flow 4-25 ml/sec (mean 13.8,SD 4.52) 1-40 ml/sec (mean 14.75, SD 9.18) 0.64* Detrusor overactivity 17 patients(29.3%) 45 patients (76%) 0.05** Urodynamic SUI 4 patients (6.9%) 7 patients (12.1%) 1** * Mc Nemar Chi-square test ** T test “De novo” Symptoms are reported in Table 5 Table 5 – “De novo” symptoms LM US Stress urinary incontinence 5 (8.6%) 8 (13.8%) Urge incontinence 0 7 (12.1%) Urgency 2 (3.3%) 5 (8.6%) Increased daytime frequency 3 (5.2%) 9 (15.5%) Nocturia 6 (10.3%) 7 (12.1%) Slow stream 11 (18.9%) 5 (8.6%) Feeling of incomplete emptying 2 (3.4%) 2 (3.4%) Dyspareunia 5 (8.6%) 5 (8.6%) Constipation 7 (12.1%) 8 (13.8%) Quality of life was significantly improved in almost all domains according to the King’s Health Questionnaire, with the exception of Personal Relationships in HLM group, and General Health Perception, Sleep and Severity Measures in UVVS group. In the UVVS procedure, angulation of the left ureter with hydronephrosis was observed in 5 patients (8.6%) which was diagnosed in the immediate post-operative period and resolved after removal of the suture. No intra-operative complications occured in the HLM group. Vaginal mesh erosions were present in 12% of HLM group and 17% in UVVS group (p 0.34) Interpretation of results Both procedures provide significant anatomical correction of all vaginal segments. However the correction of the anterior segment was less effective. A possible explanation for this finding could be that the vaginal axis is displaced caudally by vault suspension. An additional aggravating factor could be the tension free application of the mesh anteriorly without anchoring sutures which does not provide adequate contrast to the tension resulting from the central segment suspension. The mean Total Vaginal Length is 7.2 cm in HLM and 8.9 cm in UVVS group (p 0.04), but this does not coincide with an improvement in sexuality, as demonstrated by incidence of post-operative dyspareunia. There is a statistically significative improvement of the voiding symptoms, prolapse-related symptoms, with a good impact on the quality of life. Concluding message This study demonstates that the two vaginal vault suspension techniques are equivalent regarding anatomy, function and QoL. UVVS has a higher incidence of major complications involving the higher urinary tract, which, in our opinion, is an important factor to consider when selecting the appropriate surgical procedure. The recent introduction of trans-perineal techniques for the correction of central vaginal prolapse seems promising, and results of ongoing trials are eagerly awaited. References 1. Urology (2000) 56 (suppl 6A ): 50- 54. 2. Am J Obstet Gynecol (1993) 168(6pt1): 1669- 74