Thesis (doctoral)--Lund University, 1994. / Added t.p. with thesis statement inserted.

Thesis--Rigshospitalet, University of Copenhagen. / Summary in English and Danish. Bibliography: p. 219-[225]

Thesis (doctoral)--Lund University, 1994. / Added t.p. with thesis statement inserted.

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Objectives: To compare single incision mini-slings (SIMS) versus standard mid-urethral sling (SMUS) in the surgical management of female stress urinary incontinence (SUI) with regards; efficacy, safety and cost-effectiveness. Methods: A multicentre randomised controlled trial (RCT) comparing SIMS-Ajust® with SMUS-TVT-OTM (1-year follow-up) was performed. In addition, a systematic review and meta-analysis of RCTs comparing SIMS versus SMUS (1-3 years follow-up) was performed, incorporating the results of the RCT. Both studies assessed post-operative pain, time to return to normal activities and work, patient-reported and objective cure rates, peri-operative complications and impact on pre-operative urgency, women's quality of life (QoL), sexual function and cost effectiveness. Results: For the RCT, 137 women were randomised (SIMS-Ajust® [n=69] vs. TVT-OTM [n=68]). The SIMS Ajust® group had significantly lower post-operative pain-profile within the first four weeks (p <0.001). There were no significant differences in patient-reported success rate (p >0.999), objective success rate (p >0.999) or re-operation rates (p= 0.721) at 1-year follow-up. For the systematic review, 670 articles were identified, and 26 RCTs (n=3308 women) were included. After excluding RCTs evaluating TVT-SecurTM (recently withdrawn from clinical practice), there were no significant differences between SIMS and SMUS in patient-reported cure rates (RR 0.94, 95% CI 0.88, 1.00) and objective cure rates (RR 0.98, 95% CI 0.94, 1.01) at a mean follow-up of 18.6 months. SIMS had significantly lower post- 1 operative pain scores (WMD -2.94; 95% CI -4.16, -1.73), and earlier return to normal activities and work (WMD -5.08; 95% CI -9.59, -0.56; and WMD -7.20; 95% CI -12.43, -1.98, respectively). Conclusion: Adjustable anchored SIMS-Ajust® appears to have more favourable recovery, pain and cost effectiveness outcomes than SMUS-TVT-OTM, whilst having similar effectiveness outcomes, at 1-year follow-up. Generally, SIMS appear to have equivalent outcomes compared with SMUS at a mean follow-up of 18-months, in terms of patient-reported cure, objective cure and impact on women's QoL and sexual function. Consequently, SIMS represent a promising group of procedures in the treatment of women with SUI, and merits further research especially in terms of longer term outcomes.

published_or_final_version / Biochemistry / Doctoral / Doctor of Philosophy

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