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- Alexandridis, Vasileios, et al.
(author)
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Retropubic slings are more efficient than transobturator at 10-year follow-up : a Swedish register-based study
- 2023
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 34:6, s. 1307-1315
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Journal article (peer-reviewed)abstract
- Introduction and hypothesis: Long-term performance of mid-urethral slings (MUS) and potential differences between the retropubic and the transobturator technique for insertion are scarcely studied. This study aims to evaluate the efficacy and safety 10 years after surgery and compare the two main surgical techniques used. Methods: Women who underwent surgery with a MUS between 2006 and 2010 were identified using the Swedish National Quality Register of Gynecological Surgery and were invited 10 years after the operation to answer questionnaires regarding urinary incontinence and its impact on quality-of-life parameters (UDI-6, IIQ-7) and impression of improvement, as well as questions regarding possible sling-related complications and reoperation. Results: The subjective cure rate reported by 2421 participating women was 63.3%. Improvement was reported by 79.2% of the participants. Women in the retropubic group reported higher cure rates, lower urgency urinary incontinence rates and lower UDI-6 scores. No difference was shown between the two methods regarding complications, reoperation due to complications or IIQ-7 scores. Persisting sling-related symptoms were reported by 17.7% of the participants, most commonly urinary retention. Mesh exposure was reported by 2.0%, reoperation because of the tape by 5.6% and repeated operation for incontinence by 6.9%, significantly more in the transobturator group (9.1% vs. 5.6%). Preoperative urinary retention was a strong predictor for impaired efficacy and safety at 10 years. Conclusions: Mid-urethral slings demonstrate good results for the treatment of stress urinary incontinence and tolerable complication profiles in a 10-year perspective. The retropubic approach displays higher efficacy than the transobturator, with no difference regarding safety.
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- Andrada Hamar, Maria, et al.
(author)
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Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur
- 2011
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In: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 22:7, s. 781-787
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Journal article (peer-reviewed)abstract
- Introduction and hypothesis: The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.Methods: We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.Results: No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).Conclusions: In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
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- Andrada Hamer, Maria, et al.
(author)
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Familial predisposition to pelvic floor dysfunction: prolapse and incontinence surgery among family members and its relationship with age or parity in a Swedish population.
- 2013
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In: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier BV. - 0301-2115. ; 170:2, s. 559-562
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Journal article (peer-reviewed)abstract
- To estimate the relationship between heredity and proband's age/parity on the risk of undergoing surgery for pelvic organ prolapse and stress incontinence. Study design: Swedish population based study. Data from two national Swedish registers were used: the Hospital Discharge Register, National Board of Health and Welfare, containing information on all in-patient surgical procedures on Swedish hospitals, and the Multi-Generation Register, Statistics Sweden, containing information on individuals belonging to the same family. Women who had a surgical procedure for urinary incontinence or genital organ prolapse between the years 1987 and 2002 were identified (probands). Mothers and sisters of the probands were identified and information on incontinence or prolapse operations was linked to those relatives from the Hospital Discharge file, after which adjusted analyses were performed.
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5. |
- Andrada Hamer, Maria, et al.
(author)
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One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.
- 2012
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462.
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Journal article (peer-reviewed)abstract
- INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. RESULTS: No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). CONCLUSION: The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.
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- Andrada, Maria
(author)
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Female urinary incontinence. A study on heredity, urodynamic and hormonal factors and the evaluation of a novel surgical technique
- 2013
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Doctoral thesis (other academic/artistic)abstract
- Abstract Pelvic floor disorders (PFD) represent a major public health issue worldwide. Aims of this work Study I: to investigate associations between preoperative resting urethral parameters (MUCP, FL and CA) and objective outcome of laparoscopic colposuspension and, if possible, to identify cutoff values useful in clinical practice. Study II: to investigate a group of perimenopausal women reporting UI regarding possible differences in serum estradiol levels among the different incontinence types. Studies III and IV: to compare retropubic TVT® with the novel TVT Secur® as surgical treatment options for SUI in terms of efficacy and safety. Study V: to estimate the degree of familial predisposition for PFD and the influence of other risk factors such as aging and parity in a Swedish population. Material and methods Study I: prospectively collected register data on 219 women with SUI operated with laparoscopic colposuspension between 1994 and 2004. Associations between objective cure and preoperative urethral parameters at rest were analyzed. Study II: clinical and laboratory data from the observational population-based ‘‘Women’s Health in the Lund Area’’ (WHILA) study, where a group of 400 perimenopausal women reporting UI answered a detailed questionnaire on their incontinence symptoms; answers were related to their serum estradiol levels. Studies III and IV: patients with primary SUI or MUI with predominant SUI symptoms were randomized between TVT and TVT Secur. Adverse events were registered and post operative outcome was blindly assessed two months (subjective cure of SUI) and one year after surgery (subjective and objective cure). Study V: Two Swedish national registers, the Hospital Discharge Register and the the Multi-Generation Register were used for the analysis. We estimated the number of women (probands), given a specific age and final parity, which were at risk and how many of them had been identified from the Hospital Discharge Register as operated for PFD. This quotient was applied to the number of relatives of that age and parity, and an expected number of operated women of each group of relatives (mothers or sisters) was calculated and compared with the observed number. A risk ratio (RR) was calculated as the quotient between the observed and expected numbers (stratified by proband age and final parity at the time of the proband’s operation and adjusting for parity in the analysis of age and for age in the analysis of parity). Results and conclusions Study I: we were not able to identify any cutoff values for MUCP, FL or CA that could be used as predictor for outcome after laparoscopic colposuspension. A combination of MUCP, FL, CA may be used to identify patients with an increased risk for surgical failure. Study II: no difference in serum estradiol levels was found among women around menopause suffering from different types of incontinence. Studies II and IV: the TVT Secur was less effective for treating SUI (both subjective and objective cure rates) and did not result in fewer complications when compared with the TVT. Study V: first grade female relatives to women operated for PFD suffer a two- to five-fold increased risk for surgery for the same conditions. Heredity seems to play a lesser role with increasing age and parity. The RR was similar for the different pelvic floor compartments within a group, suggesting a general pelvic floor disorder among relatives.
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7. |
- Andrada, Maria, et al.
(author)
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Preoperative urethral parameters at rest and objective cure following laparoscopic colposuspension.
- 2010
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462. ; 21:3, s. 331-336
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Journal article (peer-reviewed)abstract
- INTRODUCTION AND HYPOTHESIS: The aim of this study is to investigate associations between preoperative resting urethral parameters and objective outcome of laparoscopic colposuspension. METHODS: Data from 219 stress incontinent women who underwent laparoscopic colposuspension, with leakage at standardized pad test repeated after surgery, were collected. Associations between objective cure and preoperative maximum urethral closure pressure, functional urethral length, and continence area were analyzed using receiving operator characteristics curves. The level for 75% cure for each parameter was identified. RESULTS: All parameters were positively associated with cure. Continence area showed the strongest association. No cut-off values for prediction of failure were found. Women having levels equal or higher than the "75% cure level" for all urethral parameters had a cure rate of 88% compared with 55% for women with all parameters lower than this level. CONCLUSIONS: A combination of the urethral parameters may be useful for identifying patients with excellent chance for cure after colposuspension. Further studies are needed on continence area.
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8. |
- Andrada, Maria, et al.
(author)
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Serum estradiol does not differentiate stress, mixed and urge incontinent women around menopause. A report from the Women's Health in the Lund Area (WHILA) study.
- 2011
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In: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier BV. - 0301-2115. ; 159:1, s. 209-212
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To outline serum estradiol levels in perimenopausal women with stress, mixed or urge incontinence. We believe the majority of urgency symptoms in perimenopausal women to be caused by a pelvic floor dysfunction and a hypermobility of the bladder neck. If this is the case, there would be no difference in estradiol levels between the groups. STUDY DESIGN: Setting: University hospital. In the observational Women's Health in the Lund Area study, a subset of 400/2221 women reporting urinary incontinence completed a detailed questionnaire regarding lower urinary tract symptoms and had their serum steroid hormone levels measured. Statistical analyses were made by Chi-square test, nonparametrical tests, ANOVA, multi- and univariate logistic regression analysis. RESULTS: Stress incontinence was reported by 196, mixed incontinence by 153 and urge incontinence by 43 women; in 369, serumestradiol values were available. Serum estradiol did not differ significantly between stress incontinent (median 49.5pmo/l, range 2.63-875.4), urge incontinent (median 31.6pmol/l, range 2.63-460.7) or mixed incontinent women (median 35.5pmol/l, range 2.63-787.9, p=0.62). Logistic regression analysis correcting for age, parity, hormonal status, smoking, hysterectomy and BMI also failed to show any difference in estradiol levels between the groups (p=0.41-0.58). CONCLUSION: No significant differences in serum estradiol levels between stress, mixed or urge incontinent perimenopausal women could be demonstrated.
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- Dahlseng, Magnus O, et al.
(author)
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Gastrostomy tube feeding of children with cerebral palsy: variation across six European countries.
- 2012
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In: Developmental Medicine and Child Neurology. - : Wiley. - 0012-1622. ; 54:10, s. 938-944
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Journal article (peer-reviewed)abstract
- Aim To compare the prevalence of gastrostomy tube feeding (GTF) of children with cerebral palsy (CP) in six European countries. Method Data on 1295 children (754 males, 541 females; mean age 5y 11mo, range 11y 2mo, min 6mo, max 11y 8mo) with CP born from 1999 to 2001 were collected from geographically defined areas in six European countries; four of the areas covered the whole country. Distribution of CP was unilateral 37%, bilateral 51%, dyskinetic 8%, and ataxic 4%. Sixty children were classified in Gross Motor Function Classification System (GMFCS) levels I and II, 6 in level III and 34 in levels IV and Vas Outcome measures were GTF, age at placement, feeding difficulties and the children's height and weight for age standard deviation scores (z-scores). Results The use of GTF among all children with CP was highest in western Sweden (22%, 95% confidence interval [CI] 16-29), and lowest in Portugal (6%, 95% CI 3-10), northern England (6%, 95% CI 3-9) and in Iceland (3%, 95% CI 0-13; p<0.001). The difference between areas was greater among children in GMFCS levels IV and V (non-ambulant); in this group, lower height z-scores were more prevalent in the areas with lower prevalence of GTF. The children's age at placement of gastrostomy also varied between areas (p<0.002). Interpretation The observed differences in the use of GTF may reflect differences in access to treatment or clinical practice, or both. Our results suggest that the use of GTF may improve growth in height and weight among children with more severely affected gross motor function - the group most likely to have associated feeding difficulties.
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10. |
- Johnson, Gavin, et al.
(author)
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Curriculum for ERCP and endoscopic ultrasound training in Europe : European Society of Gastrointestinal Endoscopy (ESGE) Position Statement
- 2021
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In: Endoscopy. - : Georg Thieme Verlag KG. - 0013-726X .- 1438-8812. ; 53:10, s. 1071-1087
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Journal article (peer-reviewed)abstract
- The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS.This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1 Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2 Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee's procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3 Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones >10mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of >300 cases, a native papilla cannulation rate of ≥80% (90% after a period of mentored independent practice), complete stones clearance of ≥85%, and successful stenting of distal biliary strictures of ≥90% (90% and 95% respectively after a mentored period of independent practice). 4 The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of >250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥90% of cases, and an FNA/FNB accuracy rate of ≥85%. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.
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