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- 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. |
- Alexandridis, Vasileios
(författare)
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The use of implants in female pelvic floor reconstructive surgery. Short and long term efficacy and safety.
- 2023
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Pelvic floor reconstructive surgery (PFRS) has suffered from high recurrence rates ever since its birth. Implants were thus quickly employed, initially autologous grafts and allografts. Technological development led to the manufacturing of synthetic implants that were believed to provide the support needed during urinary incontinence and pelvic organ prolapse (POP) surgery. However, due to a surge of reported complications, the place of implants in PFRS remains the object of major debate. Evaluation of the long-term performance of the use of implants is critical, while efforts are made for the development of new techniques, like the single-incision slings (SIS), and new materials, like the porcine small intestinal submucosa graft (PSG).Study I is a three-year follow-up of a multicenter randomized controlled trial comparing the SIS Ajust® with conventional mid-urethral slings (MUS) for the treatment of stress urinary incontinence. Based on patient-reported outcomes, Ajust® is found to be equally effective and safe with MUS.Studies II and III utilize a register-based cohort of women to evaluate the long-term performance of MUS for the treatment of stress urinary incontinence. Ten years after surgery, MUS demonstrate good subjective results with a small decline in efficacy and acceptable complications profile. The retropubic approach displays higher long-term efficacy than the transobturator with no difference regarding safety. No difference is found between the two techniques for the application of MUS concerning dyspareunia or pelvic pain in a ten-year perspective.Study IV is a retrospective study examining the short-term complications and recurrence rates of POP surgery augmented with PSG. The relatively high recurrence rates do not suggest a clear benefit from PSG use, while pain and urinary tract symptoms hold a central position in the complications profile of PSG-augmented POP surgery.In conclusion, Ajust® appears to be equally effective and safe as MUS in a three-year setting. Retropubic slings show higher efficacy than transobturator at ten years while both techniques present good results with similar and acceptable profiles regarding complications, pain and sexual function. Finally, there are no clear benefits from the use of PSG in POP surgery.
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| 5. |
- 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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