A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair.

BACKGROUND: Obtaining intra-operative watertight closure of the dura is considered important in reducing post-operative cerebrospinal fluid (CSF) leak. The purpose of this study was to evaluate a fibrin sealant as an adjunct to sutured dural repair to obtain intra-operative watertight closure in cranial neurosurgery. METHODS: This randomized, controlled multicenter study compared a fibrin sealant (EVICEL® Fibrin Sealant [Human]) to sutured dural closure (Control). Subjects underwent supratentorial or posterior fossa procedures. Following primary dural repair by sutures, the closure was evaluated for intra-operative CSF leak by moderately increasing the intracranial pressure. If present, subjects were randomized to EVICEL® or additional sutures (2:1 ratio), stratified by surgical approach. Following treatment, subjects were successful if no CSF leaks were present during provocative challenge. Safety was assessed to 30 days post-surgery, including incidence of CSF leakage. RESULTS: One hundred and thirty-nine subjects were randomized: 89 to EVICEL® and 50 to Control. Intra-operative watertight closure was achieved in 92.1% EVICEL®-treated subjects versus 38.0% controls; a treatment difference of 54.1% (p < 0.001). The treatment differences in the supratentorial and posterior fossa strata were 49.1% and 75.7%, respectively (p < 0.001). The incidence of adverse events was similar between treatment groups. No deaths or unexpected serious adverse drug reactions were reported. CSF leakage within 30 days post-operatively was 2.2% and 2.0% in EVICEL® and control groups, respectively. In addition, 2 cases of CSF rhinorrhoea were observed in the EVICEL® group. Although not associated with the suture line where EVICEL® was applied, when combined with the other CSF leaks, the observed leak rate in the EVICEL® group was 4.5%. CONCLUSIONS: These results indicate that EVICEL® is effective as an adjunct to dural sutures to provide watertight closure of the dura mater in cranial surgery. The study confirmed the safety profile of EVICEL®.

Assessment of the psychometric properties of the Short-Form Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) following surgical placement of Prolift+M: a transvaginal partially absorbable mesh system for the treatment of pelvic organ prolapse.

INTRODUCTION: Impairment of sexual function is a significant problem among women suffering from pelvic organ prolapse (POP). Because anatomical measures of POP do not always correspond with patients' subjective reports of their condition, patient-reported outcome measures may provide additional valuable information regarding the experiences of women who have undergone surgery. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, widely used condition-specific questionnaire focused on sexual function among patients with POP or urinary incontinence. AIM: This study aims to report sexual function outcomes as measured by PISQ-12 and to evaluate the psychometric characteristics of the questionnaire following surgical mesh implant for the treatment of POP. MAIN OUTCOME MEASURES: The PISQ-12 was used to measure sexual function, while a set of other measures, namely, Pelvic Organ Prolapse Quantification, Patient Global Impression of Change, Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Surgical Satisfaction Questionnaire, was used for validation. METHODS: Data for the study were collected from a prospective multicenter, single-arm study of surgical POP repair via the transvaginal placement of a partially absorbable mesh system. For baseline, month 3, and month 12 following POP surgery, several psychometric properties of the PISQ-12 were evaluated, including internal consistency (Cronbach's alpha), concurrent validity, discriminant validity, and responsiveness. RESULTS: As measured by the PISQ-12 questionnaire, statistically significant improvements were observed in the composite summary score as well as all three subscale scores at 1 year. The PISQ-12 generally demonstrated good psychometric properties including internal consistency reliability, validity, and responsiveness. The PISQ-12 items had good distributional properties at baseline, with substantial ceiling effects at follow-up visits reflecting improvements experienced by the patients. CONCLUSION: The PISQ-12 is a valid measure of sexual function in studies involving patients with POP.

Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes.

OBJECTIVE: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh. STUDY DESIGN: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change. RESULTS: Anatomic success, defined as prolapse stage ≤ I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.0-84.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be "much better." Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year. CONCLUSION: These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns.

One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device.

OBJECTIVE: The purpose of this study was to evaluate outcomes after standardized transvaginal prolapse repair with nonanchored mesh and a vaginal support device. STUDY DESIGN: Postoperative vaginal support was assessed by pelvic organ prolapse quantitative examination after repair of symptomatic stage II/III prolapse. Validated questionnaires assessed pelvic symptoms and sexual function. Visual analog scales quantified experience with the vaginal support device. RESULTS: One hundred thirty-six women received the planned surgery; 95.6% of the women returned for the 1-year assessment: 76.9% of the cases were stage 0/I; however, in 86.9% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms, quality of life, and sexual function improved significantly from baseline (P < .05). Median visual analog scale scores for vaginal support device awareness and discomfort were 2.6 and 1.2, respectively (0 = none; 10 = worst possible). CONCLUSION: Vaginal support, pelvic symptoms, and sexual function improved at 1 year, compared with baseline, after trocar-free prolapse repair with nonanchored mesh and a vaginal support device.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

Psychometric evaluation of health-related quality-of-life measures after pelvic organ prolapse surgery.

OBJECTIVE: To evaluate the psychometric characteristics of the Pelvic Floor Distress Inventory (PFDI-20), the Pelvic Floor Impact Questionnaire (PFIQ-7), and the Patient Global Impression of Change (PGIC) among women undergoing pelvic organ prolapse (POP) repair surgery. METHODS: Data were collected at baseline and 12 months from 2 single-arm trials of surgical repair of POP using mesh. At each time point, internal consistency reliability (Cronbach's α) was calculated for the PFDI-20 and PFIQ-7 total scores and for each subscale. Concurrent validity was assessed with baseline and follow-up data using Spearman's rank-order correlation coefficients. Responsiveness was assessed by calculating change scores from baseline to each follow-up visit, effect sizes, standard error of measurement (SEM), and using PFDI-20 and PFIQ-7 change scores stratified by PGIC. RESULTS: The women (N=275: study 1, n=148; study 2, n=127) had a mean (SD) of 64.4 (10.3) years of age. At baseline, the women had a mean (SD) stage II (n=83), stage III (n=173), or stage IV (n=19) POP quantification. At baseline, the internal consistency reliability of the PFDI-20 full and subscales ranged from 0.64 to 0.85, and that of the PFIQ-7 ranged from 0.89 to 0.96. Concurrent validity was good for the PFDI-20 and PFIQ-7 (r range, 0.35-0.59). The PFDI-20, the PFIQ-7, and the PGIC were responsive. CONCLUSION: The PFDI-20, the PFIQ-7, and the PGIC are psychometrically sound measures of patients' perceptions of change after POP surgery and will be useful for those interested in evaluating perceptions of patients undergoing surgical POP repair.