| 1. |
- Alexandridis, Vasileios, et al.
(författare)
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Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence : a 3-year follow-up of a randomized controlled trial
- 2019
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 30:9, s. 1465-1473
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesis: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
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| 2. |
- Alexandridis, Vasileios, et al.
(författare)
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Efficacy and safety of pelvic organ prolapse surgery with porcine small intestinal submucosa graft implantation
- 2021
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Ingår i: European Journal of Obstetrics and Gynecology and Reproductive Biology. - : Elsevier BV. - 0301-2115. ; 267, s. 18-22
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The ideal implant material for the surgical repair of pelvic organ prolapse in women is yet to be found. This retrospective study aims to evaluate a porcine small intestinal submucosa (SIS) graft (Surgisis™). Study design: We reviewed the medical records of women that were operated upon for pelvic organ prolapse using implantation of SIS graft and we examined the short-term complications and recurrence rates. Results: A total of 155 surgical procedures were reviewed. SIS graft was placed in the anterior, posterior and middle compartments in 93 (60%), 71 (45.8%) and 13 (8.4%) cases, respectively. At three-month follow-up, 22.6% of anterior graft repairs displayed anatomical recurrence (POP-Q stage ≥ 2), compared to 4.8% of posterior and none of the middle compartment graft repairs. During the three postoperative months, 56% of the women were recorded with complications, mostly urinary retention (19%) and pain (12%). The incidence of grade III complications was 5.3%. Persistent complications at three months were observed in 28% of all cases. Logistic regression analysis showed that previous prolapse surgery at the same compartment was a significant predictor for recurrence of prolapse after SIS graft application, whereas lower age, smoking and longer duration of surgery were significant predictors for the development of complications. Younger women had higher risk of developing pain postoperatively. Conclusion: Pain and urinary tract symptoms hold a central position in the complications profile of SIS graft-augmented prolapse surgery. The relatively high recurrence rates do not suggest a clear benefit from SIS graft use.
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| 3. |
- Alexandridis, Vasileios, et al.
(författare)
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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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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 34:6, s. 1307-1315
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Tidskriftsartikel (refereegranskat)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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| 4. |
- Andrada Hamar, Maria, et al.
(författare)
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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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Ingår i: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 22:7, s. 781-787
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Tidskriftsartikel (refereegranskat)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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| 5. |
- Andrada Hamer, Maria, et al.
(författare)
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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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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462.
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Tidskriftsartikel (refereegranskat)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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| 6. |
- Andrada, Maria, et al.
(författare)
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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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Ingår i: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier BV. - 0301-2115. ; 159:1, s. 209-212
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Tidskriftsartikel (refereegranskat)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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| 7. |
- Edqvist, Malin, et al.
(författare)
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The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus) : a multicentre, randomised controlled trial in Sweden
- 2022
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 399:10331, s. 1242-1253
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.METHODS: In this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18-47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.FINDINGS: Between Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49-0·97).INTERPRETATION: The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.
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| 8. |
- Edqvist, Malin, et al.
(författare)
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The Effect of Two Midwives During the Second Stage of Labour to Reduce Severe Perineal Trauma (Oneplus) : A Multicentre, Randomized Controlled Trial in Sweden
- 2022
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Ingår i: Obstetrical and Gynecological Survey. - : Ovid Technologies (Wolters Kluwer Health). - 0029-7828 .- 1533-9866. ; 77:9, s. 513-515
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Tidskriftsartikel (refereegranskat)abstract
- In many high-income countries, severe perinatal trauma (SPT), affecting the anal sphincter muscle complex, has been on the rise over the last decade. However, effective strategies to prevent SPT are scarce. In randomized controlled trials, only perineal warm compresses and massage have shown benefit. Other cohort studies have shown that prevention models involving several components can decrease the occurrence of SPT, including a stepped-wedge design that reduced SPT from 3.3% to 3.0%. In Scandinavia, a preventive strategy called collegial assistance has been used to help prevent SPT. This strategy involves 2 mid-wives who assist the woman in the second stage of labor, with the second midwife primarily focused on preventing SPT. The aim of this study was to compare the rate of SPT in pregnancies managed by collegial assistance versus a single midwife. This Oneplus study was a randomized, controlled, unmasked trial, conducted at 5 obstetric units in Sweden between December 10, 2018, and March 21, 2020. Included were adult women with uncomplicated singleton pregnancies at >37 weeks of gestation, who were carrying their first child or having their first vaginal birth after cesarean delivery. Excluded were women who had multiple pregnancies, had intrauterine fetal demise, were undergoing a planned cesarean section, or were at <37 weeks' gestation. Women were randomly assigned to either the intervention group with 2 midwives in attendance during active second stage labor or standard care with 1 midwife. All midwives were asked to document the preventive methods used in case report forms. A total of 3750 women were included in the final analysis-with 1879 women receiving collegial assistance and 1871 women receiving standard care. Of the women who gave birth spontaneously, 1546 were in the intervention group and 1513 in the standard care group. Severe perinatal trauma occurred less frequently in the intervention group than the standard care group (3.9% vs 5.7%; odds ratio, 0.68; 95% confidence interval, 0.49-0.97; P = 0.025). In the intervention group, 0.2% had fourth-degree tears compared with 0.5% in the standard care group. The median time for collegial assistance was 15 minutes (interquartile range, 10-20 minutes). The use of perineal warm compresses was similar in the intervention group and standard care group (86.4% vs 85.7%, respectively). No differences were observed in birth positions, manual perineal protection, neonatal outcomes, or secondary maternal outcomes. In conclusion, the attendance of a second midwife dedicated to preventing SPT during the second stage of labor significantly reduced the risk of injury.
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| 9. |
- Edqvist, Malin, et al.
(författare)
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The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus) : a multicentre, randomised controlled trial in Sweden
- 2022
-
Ingår i: The Lancet. - : Elsevier. - 0140-6736 .- 1474-547X. ; 399:10331, s. 1242-1253
-
Tidskriftsartikel (refereegranskat)abstract
- BackgroundSevere perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.MethodsIn this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18–47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.FindingsBetween Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49–0·97).InterpretationThe presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.FundingThe Swedish Research Council for Health, Working Life and Welfare; Jan Hains Research Foundation; and Skane County Council's Research and Development Foundation.
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| 10. |
- Gunnarsson, Marianne, et al.
(författare)
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Effects of pelvic floor exercises in middle aged women with a history of naïve urinary incontinence: a population based study.
- 2002
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Ingår i: European Urology. - 1873-7560. ; 41:5, s. 556-561
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To follow the effect of a 4-month pelvic floor exercise (PFE) program in women with naïve urinary incontinence with vaginal electromyography (EMG), pressure and palpation and also to compare the initial findings with symptom-free women of the same age.METHODS: The pelvic floor function expressed with vaginal EMG, pressure and palpation was measured before, during and after 4 months of PFEs in 60 previously untreated incontinent women, 50 of whom completed the study. The patients' perception of the situation and the amount of leakage were estimated before and after PFE. The incontinent group was compared at baseline and after PFE with 28 healthy controls. All women in this study (age 53-63) were randomly recruited from a major population based study.RESULTS: At baseline, the incontinent women had significant reductions of both vaginal EMG activity and pelvic floor muscle condition as estimated by palpation compared to the healthy group. During training a successive, significant increase was seen in both EMG, pressure and palpation and the values eventually exceeded those of the healthy women. The measures reflecting improvement of pelvic floor function thus showed a consistent and progressive pattern. The degree of improvement was higher in those with initial high values in the muscle function tests than in the women with lower initial EMG values, pressures and findings on palpation. No differences were seen between patients with a history of stress incontinence and patients with an urge component, i.e. urge or mixed incontinence. Sixty-four percent of the women were satisfied and wanted no further treatment. The median leakage at pad-test decreased from 5 (range 0-328) to 1 (range 0-126) g/24h. The correlation between the vaginal and the pad-test measurements was weak.CONCLUSION: Women with urinary incontinence have a significant reduction of pelvic floor function as estimated with vaginal EMG and palpation as compared to symptom-free controls. A successive normalization of vaginal EMG, pressure and findings at palpation was seen during the 4-month training period. Incontinence of both stress type and with an urge component can be alleviated in most of the women with PFE. These methods might be useful for routine evaluation of the pelvic neuromuscular disorder present in incontinent women.
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