Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial (original) (raw)
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Urogynaecologia, 2022
The use of vaginal mesh in order to correct Pelvic Organ Prolapse (POP) has been banned by the FDA due to the complications associated with them. The objective is to determine efficacy and safety in the short and long term in a sample of women undergoing transvaginal mesh surgery performed by properly trained surgeons, in a referral center and with a protocolized follow-up. We present a longitudinal, descriptive study of a cohort of 53 patients with POP who underwent transvaginal mesh surgery between 2001 and 2015. The efficacy of the treatment is evaluated quantifying both clinical changes and life quality, as well as the rate for prolapse recurrence and the short-and long-term treatment-related complications. A total of 53 patients with average follow-up of 87 months were included. All of them had their surgery performed by three properly-trained surgeons. Indication for mesh placement was assessed in 49.1% of cases due to previous surgery recurrence. Treatment improved urinary in...
International journal of clinical urology, 2018
Objective: We assess the anatomical and functional results of pelvic organ prolapse (POP) repair with application of transvaginal synthetic meshes. Keywords: pelvic organ prolapse, vaginal repair, urogynecology. Methods: We analyzed a cohort of 105 women who underwent transvaginal pelvic floor repair using mesh (Elevate Prolapse Repair System). A gynecological examination, cough test, uroflowmetry and an administration of the overactive bladder Awareness Tool were done. Parametric and nonparametric methods of descriptive statistics, as well as logistic regression were used for data analysis. Results: Prolapse recurrence after vaginal repair was noted in 3.81% (n=4) of patients. The proportion of patients with de novo onset of incontinence after surgery was 8.57% (n=9). In 26.7% (n=28) of women with stress urinary incontinence (SUI), SUI symptoms persisted after surgery. The mean Q max in the patient group was 19.5 ml/s. The mean Q max in patients reporting bladder-emptying problems was 14 ml/s, and the mean post-void residual (PVR) was 50±15.0 ml. After surgery, the mean Q max increased to 27.6 ml/s. The PVR after surgery decreased to 30±5.0 ml. The number of patients with bladder outlet obstruction symptoms decreased to 17 (16.19%). Conclusion: The management of genital prolapse with synthetic prostheses interposed through vaginal approach is an efficient method with good midterm outcomes.
Evaluating the efficacy of the single-incision uphold system for pelvic organ prolapse repair
Taiwanese Journal of Obstetrics and Gynecology, 2019
The aim of this study was to assess the efficacy and clinical outcomes of pelvic floor reconstruction with transvaginal mesh of the Uphold™ Vaginal Support System (Boston Scientific Corporation). Materials and methods: This retrospective study reviewed the medical records of patients with pelvic organ prolapse stage 3 or 4 who underwent pelvic reconstructive surgery with transvaginal mesh of the Uphold™ Vaginal Support System from January 2015 to March 2017. Patients who were treated with laparoscopic sacrocolpopexy, transvaginal sacrospinous ligament suspension or other mesh kits were excluded. Assessments included pre-and postoperative Pelvic Organ Prolapse Quantification (POP-Q) stage, Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), urodynamic parameters, peri-and postoperative complications and symptoms. Results: Of the 111 enrolled women, the anatomical success rate was 97.3% after a median 18.4 months of follow-up. POP-Q parameters, UDI-6 and IIQ-7 scores, maximum urine flow rate, and post-void residual urine all significantly improved after surgery. Complications included one case (0.9%) of infected hematoma, two cases (1.8%) of mesh exposure, three cases (2.7%) of recurrent prolapse, and 12 cases (10.8%) of transient urine retention. No bladder or bowel injuries occurred during surgery. Conclusions: Pelvic reconstructive surgery with transvaginal mesh of the Uphold™ System yielded satisfactory anatomical and urinary functional outcomes in a median 18.4 months of follow-up.
Trends in use of surgical mesh for pelvic organ prolapse
American Journal of Obstetrics and Gynecology, 2013
OBJECTIVE: Limited data exist on the rates of pelvic organ prolapse procedures utilizing mesh. The objective of this study was to examine trends in vaginal mesh prolapse procedures (VMs), abdominal sacrocolpopexy (ASC), and minimally invasive sacrocolpopexy (MISC) from 2005 to 2010.
Mesh-related and intraoperative complications of pelvic organ prolapse repair
Central European journal of urology, 2014
To evaluate the rates of complications of pelvic organ prolapse repair and to determine their risk factors. The study included 677 patients operated for pelvic organ prolapse with trocar guided Prolift mesh. Patients were followed up within 1 and 3 months. A phone interview was conducted and patients with complaints were invited and evaluated in office settings. Mean age was 60 years. For the phone interview, 86.5% of patients were available. Overall complication rates were 22.5% (152/677). Fifteen patients (2.2%) developed bleeding over 500 cc; pelvic hematomas - 5.5%; perineal hematomas - 2.5%; urethral injuries - 0.3%; bladder injury in 1.6%; rectal damage in 0.7% and ureteral trauma in 0.2%. MESH RELATED COMPLICATIONS INCLUDED: erosions in 4.8%; vaginal synechiae - 0.3%; protrusion of mesh into the bladder - 0.15%; vesicovaginal fistula with mesh protrusion - 0.3%; mesh shrinkage - 1%; dyspareunia and pain in 2.4% cases. Pelvic abscess was found in 0.6% including one case of let...
International Urogynecology Journal, 2016
Introduction and hypothesis To compare apical correction in stage ≥3 cystocele between two mesh kits. Methods This was a retrospective, nonrandomized study that compared two groups matched on anterior/apical POP-Q stage: 84 received Elevate Ant™ single-incision mesh (Elevate Ant group) and 42 Perigee™ transvaginal mesh (Perigee group). Follow-up at 1 and 2 years comprised objective (POP-Q) and subjective (PFDI-20, PFIQ-7, PISQ-12) assessments. The primary endpoint was objective success: 2year apical POP-Q stage ≤1. Secondary endpoints were anterior POP-Q stage, subjective results and complications. Results Groups were comparable in terms of age (66.6 and 64.7 years, respectively; p = 0.19), BMI (both 25.4 kg/m 2 ; p = 0.93), and history of hysterectomy (7.2 % and 14.3 %; p = 0.21) or prolapse surgery (12 % and 14.3 %; p = 0.72). Operative time was shorter in the Elevate Ant group (54.1 vs. 62.5 min; p = 0.048), and the 2-year objective apical success rate was higher (92.9 % vs. 66.7 %; p < 0.0001), with better point C correction (−5 vs. −3.8; p = 0.006). Function improved in both groups, with significantly better PFIQ-7 (p = 0.03) and PFDI-20 (p = 0.02) scores in the Elevate Ant group at 2 years. Vaginal exposure was not seen in the Elevate Ant group but occurred in two patients in the Perigee group (p = 0.33). Factors associated with success were age >65 years (OR 7.16, 95 % CI 1.83-27.97) and treatment with Elevate Ant mesh (OR 10.16, 95 % CI 2.78-37.14). Postoperative stress urinary incontinence rate was greater with the Elevate Ant group (29.8 % and 16.7 %; p = 0.11). Conclusions The use of the Elevate Ant mesh was associated with significantly better apical correction at 2 years. Function improved in both groups, but with a significantly better PFDI-20 score in the Elevate Ant group at 1 and 2 years. The postoperative stress urinary incontinence rate, however, tended to be greater in the Elevate Ant group. The results need confirming with longer follow-up of these cohorts and in randomized studies.
Methods of surgery for pelvic organ prolapse in a nationwide cohort (FINPOP 2015)
Acta Obstetricia et Gynecologica Scandinavica, 2018
Introduction: The management of pelvic organ prolapse (POP) varies significantly between countries. The objective of this study was to describe the methods used for POP surgery in Finland and to identify the factors that affect clinicians' choice to use either a native tissue repair (NTR) or mesh repair method. Material and Methods: This prospective cohort study included 3,535 surgeries covering 83% of all POP operations performed in Finland in 2015. The operative details and patient characteristics, including the Pelvic Floor Distress Inventory (PFDI-20), were compared between three selected surgical methods (NTR, transvaginal mesh (TVM), and abdominal mesh (AM)). The predictive factors for the use of mesh augmentation were also studied with logistic regression analysis. Results: The most common method was NTR (N=2855, 81%), followed by TVM (N=429, 12%) and AM (N=251, 7%). Approximately 92% of patients who underwent primary prolapse surgery underwent NTR, and mesh surgery was used mainly for recurrent prolapse. The strongest predictor of mesh surgery was previous POP surgery for the same vaginal compartment (adjusted odds ratio (OR) = 56, 95% confidence interval (CI) = 38-84 for TVM; adjusted OR = 22, 95% CI = 14-34 for AM). Other predictive factors for mesh surgery were previous hysterectomy, healthcare district, severe bulge symptoms and advanced prolapse. TVM was associated with advanced anterior prolapse and older age. AM surgery was associated with advanced apical and/or posterior compartment prolapse. PFDI-20 scores were the highest in the AM group (108 vs 103 in the TVM group and 98 in the NTR group, p=0.012), which indicates more bothersome symptoms than in the other groups. Conclusions: The Finnish practices follow international guidelines that advocate NTR as the principal surgical method for POP. Synthetic mesh augmentation was mainly used in patients with recurrent and advanced Accepted Article This article is protected by copyright. All rights reserved. prolapse with severe symptoms. The variation in the rates of mesh augmentation for POP surgery in different hospitals implies a lack of sufficient evidence of the most suitable treatment method and indicates a need for national guidelines.
Pelvic organ prolapse repair with Prolift® mesh: a prospective study
Pelviperineology, 2009
INTRODUCTION The long term durability of conventional surgical repair of vaginal prolapse has been questioned in recent years. In a frequently quoted publication Olsen et al.1 estimated that the lifetime risk (up to age 80 years) of undergoing surgery for vaginal prolapse was ...