Ultrasound evaluation of anterior transvaginal mesh for pelvic organ prolapse: correlation to 5-year clinical outcomes.

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.

Association between surgical volumes and real-world healthcare cost when using a mesh capturing device for pelvic organ prolapse: A 5-years comparison between single- versus multicenter use.

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.

Long-term outcomes of pelvic organ prolapse repair using a mesh-capturing device when comparing single- versus multicenter use.

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.

Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients.

AIMS: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. METHODS: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires. RESULTS: Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups. CONCLUSIONS: PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC.

A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery: correlation with condition-specific outcome measures.

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.

Comparison of single- versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device.

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.

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study.

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.

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.

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.).

Clinical efficacy of a trocar-guided mesh kit for repairing lateral defects.

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.

Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.

AIMS: To determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study. METHODS: Double-blind, double-dummy, three-armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks. RESULTS: When major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the study was prematurely discontinued. Based on study-end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for ≥ 6 weeks. CONCLUSIONS: Unexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.

Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse.

AIMS: To identify risk factors for mesh exposures after anterior pelvic organ prolapse repair using a standardized trocar guided polypropylene mesh kit. METHODS: A secondary risk analysis combining patients from two prospective multicenter studies. Main outcome was clinical host-vs-implant reactions one year after surgery using a macroscopic inflammatory scale. RESULTS: 353 patients were included in the study. Mean age at surgery was 65.3 (± 9.6 SD) years and surgery was performed as a primary procedure in 224/353 (63.5%) patients. Mesh exposures, of which the majority were mild-moderate, occurred in a total of 30/349 patients (8.6%). Multivariate logistic regression showed increased odds for mesh exposures for women who smoked before surgery (OR 3.48, 95% CI 1.18-10.28), who had given birth to more than two children (OR 2.64, 95% CI 1.07-6.51) and those with somatic inflammatory disease (OR 5.11, 95% CI 1.17-22.23). Age, body mass index, and menopausal status showed no significant association with clinical mesh exposures. CONCLUSIONS: Smoking, multiple childbirth, and somatic inflammatory disease are possible risk factors for mesh exposure after trocar guided mesh kit surgery for anterior pelvic organ prolapse. Preoperative smoking cessation may decrease the risk for exposures.

Patient characteristics impacting health state index scores, measured by the EQ-5D of females with stress urinary incontinence symptoms.

OBJECTIVE: To describe the characteristics of women seeking treatment for symptoms of stress urinary incontinence (SUI) and to investigate the association of SUI symptoms with generic health-related quality of life (HRQoL) as measured by the EuroQol (EQ-5D) instrument. METHODS: The Stress Urinary Incontinence Treatment (SUIT) study was a 12-month observational study in four European countries that evaluated the cost-effectiveness of duloxetine compared with other forms of nonsurgical intervention in the treatment of the symptoms of SUI. Four hundred thirty-one physicians observed women seeking treatment for their SUI, and recorded the care provided and the outcomes of that care at enrollment and at 3, 6 and 12 months afterward The impact of SUI on baseline HRQoL as expressed by the EQ-5D index score was assessed by linear and logistic regression. RESULTS: Three thousand seven hundred sixty-two women were enrolled into SUIT, with the largest patient group from Germany. Overall, the majority of women were postmenopausal, had a mean age of 58.0 years, were not current smokers, and tended to be overweight (mean body mass index [BMI]=27.7 kg/m2), with at least one comorbidity. The health state index scores were significantly and independently influenced by the presence of comorbidity(ies) affecting quality of life, total number of stress and urge incontinence episodes, urinary incontinence subtype, comorbidity(ies) affecting incontinence, BMI, socioeconomic status, educational status, age, and country. CONCLUSION: This article describes the characteristics of patients at the SUIT enrollment visit, and demonstrates that the number of incontinence episodes has a significant impact on the EQ-5D index score.

Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh.

AIMS: To investigate the urodynamic effects of anterior vaginal wall prolapse surgery using either trocar guided transvaginal mesh or colporraphy. METHODS: A prospective, randomized multicenter trial enrolling 50 patients: 27 underwent anterior colporrhaphy and 23 anterior trocar guided transvaginal mesh. Urodynamic assessment was performed pre- and two months postoperatively. RESULTS: De novo stress urinary incontinence was significantly more common after trocar guided transvaginal mesh surgery compared to colporraphy. In comparison to baseline urodynamics, transvaginal mesh surgery resulted in a significant decrease in maximal urethral closing pressures (MUCP) whereas conventional anterior colporraphy had no significant effect on urodynamic parameters. CONCLUSION: Trocar guided transvaginal mesh of anterior vaginal wall prolapse results in a lowering of MUCPs and increases the risk for de novo stress urinary incontinence compared to colporraphy.

Effects of anterior trocar guided transvaginal mesh surgery on lower urinary tract symptoms.

AIMS: To assess the effects of trocar guided transvaginal mesh on lower urinary tract symptoms after anterior vaginal wall prolapse repair. METHODS: One hundred twenty-one patients undergoing anterior transvaginal mesh surgery was prospectively evaluated at baseline and 1 year after surgery using the urogenital distress inventory (UDI). RESULTS: Overall UDI scores declined from 91 before surgery to 31 one year after surgery (P < 0.001). UDI subscales for obstructive and irritative symptoms improved 1 year after surgery (P < 0.001 for both) while stress symptoms did not (P = 0.11). CONCLUSION: Trocar guided transvaginal mesh surgery for anterior vaginal wall prolapse was associated with an overall resolution of most symptoms associated with overactive bladder syndrome and bladder outlet obstruction. These beneficial effects should be weighed against an increased risk for stress urinary incontinence related to the procedure.

Patient reported outcomes tools in an observational study of female stress urinary incontinence.

AIMS: To determine which patient characteristics, incontinence and non-incontinence related, are associated with the symptom severity scores of the Urogenital Distress Inventory (UDI) and the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI); and to determine the association of both patient characteristics and symptom severity scores with quality-of-life scores of the Incontinence Impact Questionnaire (IIQ) and the Incontinence-Quality of Life (I-QOL) questionnaire. METHODS: Women presenting with stress urinary incontinence (SUI) symptoms in primary and secondary care entered the Stress Urinary Incontinence Treatment Study (SUIT), an observational study evaluating the cost-effectiveness of duloxetine compared to other non-surgical treatments for SUI. At enrollment patients completed the UDI-6, the short form ICIQ-UI, the IIQ-7 and the I-QOL. Multivariate linear regressions were performed with the UDI-6, ICIQ-UI SF, IIQ-7, and I-QOL as outcomes. RESULTS: The total number of incontinence episodes is the most significant explanatory variable of the two symptom questionnaire scores, but the UDI-6 score also reflects the type of incontinence. The variability of the condition-specific quality-of-life questionnaires is primarily explained by the symptom severity questionnaire scores. Although there is a high intercorrelation, both these symptom questionnaires independently contributed significantly to the IIQ-7 and I-QOL total scores. CONCLUSIONS: The UDI-6 and ICIQ-UI SF can be regarded as scientifically sound symptom questionnaires in UI evaluation; but they have differences. Since the UDI-6 and ICIQ-UI SF independently contribute to the quality-of-life scores, this suggests that in incontinence research symptom questionnaires should not focus only on incontinence, but on a broader range of urogenital symptoms.

An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.

INTRODUCTION: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence. METHODS: Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%). RESULTS: At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen. CONCLUSIONS: Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.

Histological inflammatory response to transvaginal polypropylene mesh for pelvic reconstructive surgery.

PURPOSE: We prospectively evaluated the histological inflammatory response to the large polypropylene transvaginal mesh used for pelvic organ prolapse surgery. MATERIALS AND METHODS: Ten patients and 8 controls underwent vaginal punch biopsy sampling before surgery and patients also underwent it 1 year after pelvic reconstructive surgery using polypropylene mesh. Foreign body response to the mesh was assessed using a combination of histological, semiquantitative and computerized image based analysis. RESULTS: Compared to preoperative histology there was a significant postoperative increase in macrophage and mast cell counts (p = 0.03 and 0.01) but no significant changes in the count of cells involved primarily in the infectious cell response or collagen density and the elastin area fraction at the mesh-tissue interface (p = 0.2 and 0.3, respectively). Three cases of mild granuloma formation and 2 of mild erosion were observed. There was no significant change in epithelial thickness when comparing preoperative and postoperative samples. CONCLUSIONS: When used for pelvic reconstructive surgery, macroporous monofilament polypropylene mesh induces a mild but persistent foreign body reaction.

Trocar-guided transvaginal mesh repair of pelvic organ prolapse.

OBJECTIVE: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. METHODS: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0-I was considered anatomic cure. RESULTS: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean+/-standard deviation age at surgery was 66.3+/-9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated. CONCLUSION: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844 LEVEL OF EVIDENCE: II.

Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse.

OBJECTIVE: To estimate sexual dysfunction before and after trocar-guided transvaginal mesh surgery for pelvic organ prolapse. METHODS: Sexually active women participating in a prospective multicenter study were recruited at 26 centers. All participants underwent a standardized surgical procedure and were evaluated before (n=105) and 1 year after (n=84) surgery using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Nonparametric statistics were used for comparisons. RESULTS: Mean age at surgery was 61.5 years (standard deviation [SD] 7.6), median parity was 2 (range, 1-6), and mean body mass index was 26.8 (SD 4.3) (body mass index is calculated as weight (kg)/[height m]). Anterior transvaginal mesh repair was performed in 46 patients (44%), posterior in 26 patients (25%), and combined anterior and posterior in 33 patients (31%). Overall sexual function scores worsened from 15.5 (SD 8.0) at baseline to 11.7 (SD 6.9) 1 year after surgery (P<.001). The trend toward deteriorating sexual function scores was similar for all three surgical procedures. There was an overall worsening of all symptoms in the behavioral-emotive and partner-related items, whereas improvements were observed in physical function. Overall rates and severity of dyspareunia in specific neither improved nor worsened. CONCLUSION: Sexual function scores deteriorate 1 year after trocar-guided transvaginal mesh surgery. The worsening was attributed primarily to a worsening in behavioral-emotive and partner-related items. Anatomical cure after surgery was not associated with improved PISQ scores. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844 LEVEL OF EVIDENCE: II.