Marie-Liesse de Guerry1, Amélie Demeestere1, Christophe Bergot2, Astrid de Hauteclocque3, Juliette Hascoet4, Anne-Sophie Bajeot5, Camille Ternynck6, Xavier Gamé5, Benoît Peyronnet4, Grégoire Capon3, Marie-Aimée Perrouin-Verbe2, Xavier Biardeau7,8,9. 1. University of Lille, Department of Urology, CHU Lille, F-59000, Lille, France. 2. Department of Urology, CHU Nantes, Université de Nantes, Nantes, France. 3. Department of Urology, CHU Bordeaux, Université de Bordeaux, Bordeaux, France. 4. Department of Urology, CHU Rennes, Université de Rennes, Rennes, France. 5. Department of Urology, CHU Rangueil, Université Paul Sabatier Toulouse III, Toulouse, France. 6. Department of Biostatistics, CHU Lille, 59000, Lille, France. 7. University of Lille, Department of Urology, CHU Lille, F-59000, Lille, France. biardeau.xavier@gmail.com. 8. University of Lille, Inserm UMR-S1172 LilNCog, Lille Neuroscience and Cognition, CHU Lille, FHU Precise, 59000, Lille, France. biardeau.xavier@gmail.com. 9. University of Lille, Department of Urology, Lille University Hospital, 1 rue Polonovski, 59037, Lille Cedex, France. biardeau.xavier@gmail.com.
Abstract
INTRODUCTION AND HYPOTHESIS: To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). METHODS: In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups: Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. RESULTS: Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. CONCLUSIONS: The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.
INTRODUCTION AND HYPOTHESIS: To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). METHODS: In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups: Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. RESULTS: Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. CONCLUSIONS: The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.
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