| 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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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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| 3. |
- 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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| 4. |
- 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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| 5. |
- Larsson, Per-Goran, et al.
(författare)
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A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure
- 2010
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462. ; 21:9, s. 1175-1177
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Tidskriftsartikel (refereegranskat)abstract
- We report a serious complication following a TVT-Secur procedure due to injury of the corona mortis requiring a surgical intervention for removal of 1 l of clotted blood from the space of Retzius. The corona mortis is an anomaly of the vessel combining the obturator and epigastric arteries passing over the superior pubic ramus, well known to hernia and orthopedic surgeons but probably less well known to gynecological surgeons.
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| 6. |
- Rudnicki, Martin, et al.
(författare)
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Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence : a randomized controlled trial
- 2019
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023.
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesis: The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence. Methods: This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings. Results: The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months’ follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication. Conclusions: Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.
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| 8. |
- Teleman, Pia, et al.
(författare)
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Urethral pressure response patterns induced by squeeze in continent and incontinent women.
- 2007
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Ingår i: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 1433-3023 .- 0937-3462. ; 18:9, s. 1027-1031
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Tidskriftsartikel (refereegranskat)abstract
- Our aim was to compare the urethral pressure response pattern to pelvic floor muscle contractions in 20-27 years old, nulliparous continent women (n=31) to that of continent (n=28) and formerly untreated incontinent (n=59) (53-63 years old) women. These women underwent urethral pressure measurements during rest and repeated pelvic muscle contractions. The response to the contractions was graded 0-4. The young continent women showed a mean urethral pressure response of 2.8, the middle-aged continent women 2.2 (NS vs young continent), and the incontinent women 1.5 (p < 0.05 vs middle-aged continent, p < 0.001 vs young continent). Urethral pressures during rest were significantly higher in the younger women than in both groups of middle-aged women. The decreased ability to increase urethral pressure on demand seen in middle-aged incontinent women compared to continent women of the same age as well as young women seems to be a consequence of a neuromuscular disorder rather than of age.
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| 9. |
- Lundmark Drca, Anna, et al.
(författare)
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Dyspareunia and pelvic pain: comparison of mid-urethral sling methods 10 years after insertion
- 2024
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Ingår i: International Urogynecology Journal. - 1433-3023.
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesisThe mid-urethral sling (MUS) has been used for more than 30 years to cure stress urinary incontinence. The objective of this study was to assess whether surgical technique affects the outcome after more than ten years, regarding dyspareunia and pelvic pain.MethodsIn this longitudinal cohort study we used the Swedish National Quality Register of Gynecological Surgery to identify women who underwent MUS surgery in the period 2006–2010. Out of 4348 eligible women, 2555 (59%) responded to the questionnaire sent out in 2020–2021. The two main surgical techniques, the retropubic and the obturatoric approach, were represented by 1562 and 859 women respectively. The Urogenital Distress Inventory-6 (UDI-6) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), as well as general questions concerning the MUS surgery, were sent out to the study population. Dyspareunia and pelvic pain were defined as primary outcomes. Secondary outcomes included PISQ-12, general satisfaction, and self-reported problems due to sling insertion.ResultsA total of 2421 women were included in the analysis. Among these, 71% responded to questions regarding dyspareunia and 77% responded to questions regarding pelvic pain. In a multivariate logistic regression analysis of the primary outcomes, we found no difference in reported dyspareunia (15% vs 17%, odds ratio (OR) 1.1, 95% CI 0.8–1.5) or in reported pelvic pain (17% vs 18%, OR 1.0, 95% CI 0.8–1.3) between the retropubic and obturatoric techniques among study responders.ConclusionDyspareunia and pelvic pain 10–14 years after insertion of a MUS do not differ with respect to surgical technique.
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