| 1. |
- Elmer, Caroline, et al.
(författare)
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Histological Inflammatory Response to Transvaginal Polypropylene Mesh for Pelvic Reconstructive Surgery
- 2009
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Ingår i: Journal of Urology. - : Ovid Technologies (Wolters Kluwer Health). - 0022-5347 .- 1527-3792. ; 181:3, s. 1189-1195
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Tidskriftsartikel (refereegranskat)abstract
- 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 I 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.
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| 2. |
- Elmér, Caroline
(författare)
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Transvaginal mesh for pelvic organ prolapse : clinical and histological aspects
- 2012
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The objectives of this thesis were to assess the objective, clinical, and sexual outcomes after transvaginal surgery for pelvic organ prolapse using a trocar guided mesh kit, to ascertain the vaginal in vivo histological inflammatory response to large mesh, and to identify possible risk factors associated with exposures after transvaginal mesh surgery. A prospective multicenter cohort study was performed between June 2006 and March 2007 throughout 26 clinics in the Nordic countries. The 261 women included underwent pelvic organ prolapse surgery with the Prolift® mesh kit and were examined at baseline, two months and one year regarding objective anatomic prolapse stage, signs of vaginal inflammation and subjective symptom assessment. We found satisfactory anatomic cure rates (between 79 and 86%), few serious complications (3.4%) and exposures in 11%. Subjective improvements were seen in both questionnaire scores though not specifically for stress urinary incontinence. Among women undergoing the above prospective multicenter cohort study, sexually active women were separately analyzed with regard to sexual function before and one year after surgery using a specific questionnaire. Overall symptom scores deteriorated at one year after surgery irrespective of the surgically corrected compartment and of anatomical corrective success. The deterioration was attributed primarily to behavioral-emotive and partner related items and not specifically to dyspareunia. To determine the histological inflammatory response to large vaginal mesh, a histological study was performed. Ten women undergoing prolapse surgery using mesh from the prospective cohort study above underwent vaginal punch biopsy sampling prior to surgery and one year after. The specimens were analyzed microscopically regarding inflammatory response and compared to 8 healthy controls. At one year, a persisting low grade host-implant reaction was seen in patients. Data from the above prospective cohort study was combined with data from a randomized controlled study comparing transvaginal mesh surgery for anterior prolapse with traditional plication techniques. Only women undergoing anterior repair with mesh were analyzed and potential risk factors for developing exposures were assessed. We found that women who smoked, had given birth to more than two children and who had systemic inflammatory disease had greater odds of developing exposures. In conclusion, the four studies in this thesis have shown that transvaginal mesh for pelvic organ prolapse provides satisfactory anatomical and subjective cure rates at one year with relatively few serious adverse events. However there are significant risks of deteriorated sexual function (especially in behavioral/emotive and partner related aspects), vaginal non infectious inflammation and mesh exposures. We have shown that women who smoke, have more than two children and suffer from somatic inflammatory disease are at greater risk of mesh exposures. In spite of partly encouraging results, the findings pose significant challenges to the overall success and acceptance of the procedure. Prior to recommending the use of mesh for pelvic floor correction, all available information on symptoms, the nature of the prolapse, surgical short and longterm outcomes as well as potential risks and benefits must be adequately analyzed and considered.
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| 3. |
- Gralén, Katarina, et al.
(författare)
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Clinical practice of BOTOX® treatment for overactive bladder syndrome in Sweden : an assessment of resource use and external validity
- 2017
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813.
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of this study was to assess the resource use of treating overactive bladder (OAB) patients in real-world clinical practice and to evaluate whether there is external validity in the treatment of OAB in clinical practice. Materials and methods: The study included 55 patients suffering from OAB and treated with BOTOX® at two Swedish clinics. The study was conducted as an anonymized retrospective chart review study. Results: The estimated yearly direct cost of BOTOX treatment was €902. The mean age of patients in the study was 60 years, and 85% were women. The severity of OAB before BOTOX treatment, given by the mean number of daily leakages, equalled 4.8. The median interval between treatments was 210 days. Conclusions: Patient characteristics in the real world were similar to those in the clinical trials, showing a high degree of external validity. Treatment intervals were longer in the real world than in clinical trials, indicating that treatment cost could be lower when patients are treated as observed in real-world clinical practice.
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| 4. |
- Kaliner, Helena Kopp, et al.
(författare)
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Urodynamics as a Prognosticator of Mirabegron Treatment Outcomes
- 2019
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Ingår i: Gynecologic and Obstetric Investigation. - : KARGER. - 0378-7346 .- 1423-002X. ; 84:5, s. 472-476
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To determine if findings at urodynamics prognosticate improvements in overactive bladder symptoms among women receiving mirabegron treatment.Methods: Before treatment, women completed a urodynamic investigation, a micturition diary and the Urinary Distress Inventory (UDI) with the irritative subscale UDIOAB. After 6 months mirabegron treatment, patients were clinically evaluated and completed the UDI. Associations were tested using regression analyses and nonparametric statistics.Results: Testing urodynamic variables for association with treatment effects in multiple linear regression analysis showed that lower volumes at first sensation to void significantly correlated with greater improvement in the UDIOAB after 6 months mirabegron treatment (B = 0.026, 95% CI 0.002-0.049, p = 0.034). Improvements in UDIOAB showed no correlation with presence of nocturia (p = 0.65), previous use of anticholinergics (p = 1), menopausal status (p = 1), any detrusor overactivity during filling (p = 1), phasic detrusor contractions during filling (p = 1), or detrusor overactivity during inhibition (p = 1).Conclusions: We found limited support for clinically relevant associations between findings at urodynamics and subsequent treatment outcomes for mirabegron in routine clinical practice. Our findings do not support the role of these investigations as predictors of outcomes in patients with overactive bladder symptoms.
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