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Purpose: The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for pelvic organ prolapse (POP) repair. Methods: Five years after surgery 101 (88%) at the single center were compared with 164 (81.2%) in the multicenter trial. Outcome measurements included clinical examination, prolapse-specific symptom questionnaires [Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire—short form (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)] and pain estimation by VAS (0–10). Results: Optimal apical segment outcome was 95% in the single- compared to 83.3% in the multicenter study (p < 0.001). POP recurrence in the anterior and posterior walls (POP-Q, Ba and Bp ≥ 0) was more common at the multicenter as compared to the single center [(19.8% vs 5.4%) and (26% vs 2.7%), (p < 0.001)]. Reoperations for POP and mesh-related complications were more frequent in the multicenter study [31/202 (15.3%) vs 7/116 (6.1%), p < 0.001]. Total PFDI-20, PFIQ-7 and PISQ-12 scores were comparable between the cohorts. There were no significant differences in overall pain scores in-between the cohorts during follow-up. At the single center, 1/81 patients (1.2%) had VAS 7/10, i.e. severe pain, as compared to 3/131 (2.3%) in the multicenter study (p = 0.277). Conclusions: Despite the high objective and subjective long-term effectiveness of the procedure in both regular use, and at a high-volume center, centralizing the use of a standardized capturing-device guided transvaginal mesh for POP repair reduced secondary interventions by more than half. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The aim of this study was to investigate the use of a generic and globally accessible instrument for assessing health-related quality of life (HR-QoL) in pelvic organ prolapse (POP) surgery.Methods: In a prospective multicenter setting, 207 women underwent surgery for apical prolapse [stage ≥2, Pelvic Organ Prolapse Quantificcation (POP-Q) system] with or without anterior wall defect. Demographic and surgical characteristics were collected before surgery. Results of the 15-dimensional (15D) instrument and condition-specific pelvic floor symptoms as assessed using the Pelvic Floor Distress Inventory questionnaire (PFDI-20), including its subscales Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6), were assessed preoperatively and 2 months and 1 year after surgery.Results: HR-QoL as estimated by 15D was improved 1 year after surgery (p < 0.001). Prolapse-related 15D profile-index measures (excretion, discomfort, sexual activity, distress, and mobility) were significantly improved after surgery (p < 0.05-0.001). Significant inverse associations were detected between increased 15D scores and a decrease in PFDI-20 and subscale scores (p < 0.001), indicating improvements on both instruments.Conclusions: Generic HR-QoL as estimated by 15D improved significantly after apical POP surgery and correlated with improvements of condition-specific outcome measures. These results suggest that a comprehensive evaluation of global HR-QoL is valid in assessing pelvic reconstructive surgery and may provide novel and important insights into previously understudied areas, such as cost-utility and cost-effectiveness analysis after urogynecological surgery. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The aim of this study was to compare the results of pelvic organ prolapse repair using a capturing device-guided transvaginal mesh in a single- vs multicenter setting. Methods: One hundred and twelve women operated by two surgeons at one center (2-year follow-up) were compared with 207 women operated on by 26 surgeons at 24 centers (1-year follow-up). Patients were screened at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Outcome measurements included POP-Q evaluations, prolapse-specific symptom questionnaires, and surgical data. Results: At the end of follow-up 95 out of 98 (96.9%) had an optimal anatomical outcome at the apical segment (POP-Q stage 0-1) in the single center compared with 154 out of 164 (93.9%) in the multicenter study ( P = 0.03). There were no serious complications in the single-center study compared with 9 out of 207 (4.3%) in the multicenter study. In patients undergoing surgery for recurrence, the risk ratio for complications overall was 4:1 in favor of the single-center study. There were no significant differences between the studies in any subjective symptom scale. Conclusions: Compared with multicenter use, large volumes at a single site only resulted in minor improvements of anatomical outcomes and no significant differences with regard to patient-reported outcomes on pelvic organ function or related quality of life. Instead, the greatest benefit of single-center use was the significantly decreased complication rates. [ABSTRACT FROM AUTHOR]

Objective: To study the effects on quality of life in women operated for apical pelvic organ prolapse using the Vaginal Uphold™ System.Study Design: In this prospective cohort study, women (n=207) with symptomatic apical prolapse, with or without cystocele, were operated using the Uphold™ Vaginal Support System. Follow-up for quality of life was performed at 12 months after surgery, and assessed by the PFDI-20, and PFIQ-7, and sexual function by the PISQ-12. We used odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression.Results: At one-year follow-up majority of women experienced an overall postoperative improvement in quality of life (p<0.001). One year after surgery Uphold™ operation alone increased the risk for prolapse related bother as compared to Uphold™ combined with anterior colporraphy (POP-IQ-7; OR 2.1; 95% CI 1.01-4.3). The frequency of dyspareunia decreased postoperatively (p=0.004), however, after one-year, overall sexual function deteriorated significantly (p<0.001). The worsening in sexual function scores was mainly attributed to the partner related domain, whereas the behavioral-emotive and physical domains showed no significant changes.Conclusion: Apical prolapse repair using Uphold™ improved quality of life among our patients but worsened overall sexual function postoperatively. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System. Methods: We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale. Results: The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone re-operations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients ( p < 0.001). Pain after 2 months and 1 year was 60 % lower compared with the preoperative mean ( p < 0.001). Minor complications occurred in 20 women (9.7 %) and were dominated by lower urinary tract dysfunction. No predisposing risk factors for complications were found. Conclusions: The Uphold™ Lite procedure in women with apical pelvic organ prolapse provided satisfactory restoration of vaginal topography and symptom relief. However, serious complication rates were largely comparable with those of other transvaginal mesh kits. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The optimal surgery for lateral defects is not well defined. Our objective was to assess the effects of anterior trocar-guided transvaginal mesh repair versus anterior colporrhaphy in women with lateral defects. Methods: This subanalysis from a randomized controlled trial of mesh kit versus anterior colporrhaphy assessed 99 patient diagnosed at baseline with lateral defects in the anterior vaginal wall. Thirty-nine patients underwent anterior colporrhaphy and 60 anterior trocar-guided transvaginal mesh surgery. Results: One year after surgery, a persistent lateral defect was significantly more common after colporrhaphy compared with transvaginal mesh [11/32 (34.4 %) vs 1/42 (2.4 %), risk ratio (RR) 14.4, 95 % confidence interval (CI) 2.0-106.1; P < 0.001)] However, there were no significant differences between treatment groups with regard to subjective symptoms as reflected by the overall Urogenital Distress Inventory scores, with mean difference from baseline 37.3 ± 50.6 in the colporrhaphy group vs 39.0 ± 45.8 in the mesh group ( p = 0.61). Conclusions: Use of a transvaginal mesh kit increases the odds for anatomical correction of lateral defects compared with anterior colporrhaphy but does not necessarily improve lower urinary tract symptoms. [ABSTRACT FROM AUTHOR]

Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.) N Engl J Med 2011;364:1826-36. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To determine the genetic and environmental influence on the liability for stress urinary incontinence and pelvic organ prolapse surgery. Methods: We used the Swedish Twin Registry to identify all same-sex female twin pairs with known zygosity born from 1926 to 1958. Occurrence of stress urinary incontinence and pelvic organ prolapse surgery was determined by cross-linkage to the Swedish Inpatient Registry. By comparing mono- and dizygotic female twins, we determined twin similarity and the relative proportions of phenotypic variance resulting from genetic and environmental factors. Using statistical modelling, the liability for pelvic floor surgery explained by heritability versus shared and non-shared environmental effects was estimated. Results: We identified 3376 complete monozygotic and 5067 dizygotic same-sex female twin pairs. There was greater twin similarity among monozygotic compared with dizygotic twins, which indicates the influence of a genetic component to the aetiology of both stress urinary incontinence and pelvic organ prolapse surgery. For both disorders, genetic and non-shared environmental factors equally contributed about 40% of the variation in liability. Shared environment accounted for approximately one fifth of the total variance for the two disorders. Conclusions: Genetic effects contribute to the occurrence of both stress urinary incontinence and pelvic organ prolapse, but the influence of environmental factors is substantial. Significant environmental effects suggest that the liability for benign pelvic floor surgery is amenable to intervention. [Copyright &y& Elsevier]

Introduction and hypothesis: Vaginal prolapse mesh may effectively restore vaginal anatomy. The aim of this study was to investigate how the in vivo mesh position correlates to clinical outcomes. Methods: Seventy-one women operated on using Uphold mesh for apical pelvic organ prolapse (POP-Q, C ≥ stage II) were examined 5 years after surgery by introital-perineal 2D ultrasound in a midsagittal plane at rest and Valsalva. The horizontal line and pubis symphysis were considered the reference for all measures. Ultrasound measures were statistically compared to clinical outcomes: POP-Q, Pelvic Floor Distress Inventory (PFDI-20) and subscales [Pelvic Organ Distress Inventory (PODI-6), and Urinary Distress Inventory (UDI-6)] and the VAS scale for pain. Results: Original mesh length was preserved by 86% and correlated to improved pain as estimated by VAS scale (r 0.321). Valsalva was associated with a lowering of the superior and inferior mesh margins by 7.3 and 6.1 mm, respectively (p < 0.001) but a reduction of total mesh length by only 1 mm (30.2 ± 5.2 to 29.2 ± 4.7 mm, p < 0.001). Mobility of the anterior vaginal wall (bladder neck and midurethra) at Valsalva was parallel to downward movement of the mesh inferior margin (r 0.346 and 0.314) but inversely correlated to total UDI-6 (r − 0.254 and − 0.263). Mobility of the midurethra was inversely correlated to bladder emptying (PFDI-20 Question 19, r − 0.245). Conclusions: Five years after surgery, preserved original length of the mesh with apical support was correlated to improved anatomical and patient-reported outcomes. Mesh support to the vaginal apex was associated with improved bladder emptying and total urinary distress outcomes but not stress urinary incontinence. [ABSTRACT FROM AUTHOR]

The article discusses some of the methodological aspects of surgical trials involving pelvic organ prolapse. It states that the decision to perform pelvic reconstructive surgery is not only based on a centimeter grading of vaginal topography but to a number of factors. It mentions that although the issue of mesh exposure/erosion is significant, it is hard to believe that individual investigators would delay the treatment to improve the trial outcomes.

Introduction and hypothesis: The aim of this study was to evaluate whether high surgical volume at a single center was associated with lower healthcare costs compared to lower surgical volume in a multicenter setting. Methods: All patients had symptomatic and anatomical apical prolapse (POP-Q ≥ stage II) with or without cystocele and were operated on by a standard surgical procedure using the Uphold mesh. Data on time of resource use in terms of surgery time, hospital stay and re-interventions across 5 years were compared between the single center (97 patients) and multicenter (173 patients, at 24 clinics). Unit costs for surgical time, inpatient and outpatient visits were extracted from the single-center hospital's operation analysis program and prime production cost. Total costs were estimated for primary surgery and during 5-year follow-up. Results: Costs for primary surgery were comparable between the single and the multicenter ($13,561 ± 2688 and $13,867 ± 1177, P = 0.29). Follow-up costs 5 years after primary surgery were 2.8 times higher at the multicenter than single center ($3262 vs. $1149, P < 0.001). Mean cost per patient over 5 years was significantly lower at the single than multicenter [$14,710 (CI: 14,168–15,252) vs. $17,128 (CI: 16,952–17,305), P < 0.001)]. Conclusions: Using a mesh kit for apical pelvic organ prolapse in a high surgical volume center was associated with reduced healthcare costs compared with a lower volume multiple-site setting. The cost reduction at the high surgical volume center increased over time because of lower surgical and medical re-intervention rates for postoperative complications and recurrence. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: This study aims to determine the risk of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) surgery related to mode of hysterectomy focusing on vaginal hysterectomy. Methods: We performed a nationwide cohort study. Women exposed to hysterectomy on benign indications ( n = 118,601) were compared to women unexposed to hysterectomy ( n = 579,200). The outcome was defined as first occurrence of POP or SUI surgery. Hazard ratios (HRs) were calculated with 95% confidence intervals (CIs) using Cox proportional-hazards models. Results: The greatest risks of POP (HR 4.9, 95% CI 3.4-6.9) or SUI surgery (HR 6.3, 95% CI 4.4-9.1) were observed subsequent to vaginal hysterectomy for pelvic organ prolapse. Having a vaginal hysterectomy for other reasons also significantly increased the risks of POP and SUI surgery compared to other modes of hysterectomy. Conclusions: Hysterectomy in general, in particular vaginal hysterectomy, was associated with an increased risk for subsequent POP and SUI surgery. [ABSTRACT FROM AUTHOR]