Bara Barakat1, Sameh Hijazi2, Thomas-Alexander Vögeli3. 1. Department of Urology and Pediatric Urology, Hospital Viersen, Viersen, Germany. 2. Department of Urology, Hospital Ibbenbüren, Ibbenbüren, Germany. 3. Department of Urology and Pediatric Urology, University Hospital RWTH Aachen, Aachen, Germany.
Abstract
OBJECTIVE: To evaluate the safety and efficacy rate of polyvinylidene fluoride (PVDF) slings in the treatment of female stress urinary incontinence (SUI). MATERIAL AND METHODS: A prospective pilot study was conducted with women with SUI who underwent PVDF slings. Data regarding subjective (International Consultation on Incontinence Questionnaire - Urinary Incontinence [ICIQ-UI] and International Consultation on Incontinence Questionnaire - Overactive Bladder [ICIQ-OAB]) and objective (stress test and bladder diary) outcomes and complication rates were evaluated. Primary outcomes were objective (negative pad and stress test) and subjective (no leakage episodes) success after a median follow-up of 24 months. RESULTS: PVDF slings demonstrated a high level of satisfaction with objective cure (transobturator 90% compared with retropubic 100%, P = .90), urgency to urinate, frequency of de novo incontinence (transobturator 90% compared with retropubic 80%, P = .85), ability of physical and sexual activity (transobturator 90% compared with retropubic 100%, P = .90). The multivariate logistic regression model for satisfaction was associated with overall treatment success (odds ratio [OR] = 3.55, 95% confidence interval [CI] 2.32-6.1), greater reduction in ICIQ-UI (OR = 0.85; 95% CI 0.78-1.85) and ICIQ-OAB (OR =0.99; 95% CI 0.89-1.78). The total Female Sexual Function Index (FSFI) score for both groups was 19.3 ± 1.2 and 20.7 ± 1.8, statistically significant when compared with perioperative FSFI score 16.7 ± 1.1 and 17.6 ± 1.4 (P < .001). CONCLUSION: PVDF mid-urethral slings are safe with clinically efficacies at 3, 6, 12, and 24-month follow-up for the treatment of SUI. The high level of satisfaction seen after PVDF sling procedures is associated with objective improvement of SUI and fewer slings related complications. Further studies using larger sample sizes with longer and comparative clinical follow-up are required.
OBJECTIVE: To evaluate the safety and efficacy rate of polyvinylidene fluoride (PVDF) slings in the treatment of female stress urinary incontinence (SUI). MATERIAL AND METHODS: A prospective pilot study was conducted with women with SUI who underwent PVDF slings. Data regarding subjective (International Consultation on Incontinence Questionnaire - Urinary Incontinence [ICIQ-UI] and International Consultation on Incontinence Questionnaire - Overactive Bladder [ICIQ-OAB]) and objective (stress test and bladder diary) outcomes and complication rates were evaluated. Primary outcomes were objective (negative pad and stress test) and subjective (no leakage episodes) success after a median follow-up of 24 months. RESULTS: PVDF slings demonstrated a high level of satisfaction with objective cure (transobturator 90% compared with retropubic 100%, P = .90), urgency to urinate, frequency of de novo incontinence (transobturator 90% compared with retropubic 80%, P = .85), ability of physical and sexual activity (transobturator 90% compared with retropubic 100%, P = .90). The multivariate logistic regression model for satisfaction was associated with overall treatment success (odds ratio [OR] = 3.55, 95% confidence interval [CI] 2.32-6.1), greater reduction in ICIQ-UI (OR = 0.85; 95% CI 0.78-1.85) and ICIQ-OAB (OR =0.99; 95% CI 0.89-1.78). The total Female Sexual Function Index (FSFI) score for both groups was 19.3 ± 1.2 and 20.7 ± 1.8, statistically significant when compared with perioperative FSFI score 16.7 ± 1.1 and 17.6 ± 1.4 (P < .001). CONCLUSION: PVDF mid-urethral slings are safe with clinically efficacies at 3, 6, 12, and 24-month follow-up for the treatment of SUI. The high level of satisfaction seen after PVDF sling procedures is associated with objective improvement of SUI and fewer slings related complications. Further studies using larger sample sizes with longer and comparative clinical follow-up are required.
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