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.
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Abbreviations
- ACT®:
-
Adjustable Continence Therapy
- AUS:
-
artificial urinary sphincter
- EAU:
-
European Association of Urology
- ISD:
-
intrinsic sphincter deficiency
- NRS:
-
numerical rating scale
- OAB:
-
overactive bladder
- TNS:
-
tibial nerve stimulation
- PVR:
-
post-void residual
- Qmax:
-
maximun flow rate
- SNM:
-
sacral nerve modulation
- SUI:
-
stress urinary incontinence
- UI:
-
urinary incontinence
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Marie-Liesse de Guerry: Protocol/project development, Data collection or management,
Data analysis, Manuscript writing/editing
Amélie Demeestere: Data collection or management, Manuscript writing/editing
Christophe Bergot: Data collection or management, Manuscript writing/editing
Astrid de Hauteclocque : Data collection or management, Manuscript writing/editing
Juliette Hascoet : Data collection or management, Manuscript writing/editing
Anne-Sophie Bajeot : Data collection or management, Manuscript writing/editing
Camille Ternynck : Data collection or management, Manuscript writing/editing
Xavier Gamé : Protocol/project development, Manuscript writing/editing
Benoît Peyronnet : Protocol/project development, Manuscript writing/editing
Grégoire Capon : Protocol/project development, Manuscript writing/editing
Marie-Aimée Perrouin-Verbe : Protocol/project development, Manuscript writing/editing
Xavier Biardeau : Protocol/project development, Data collection or management,
Data analysis, Manuscript writing/editing
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de Guerry, ML., Demeestere, A., Bergot, C. et al. Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication. Int Urogynecol J 34, 877–883 (2023). https://doi.org/10.1007/s00192-022-05275-6
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DOI: https://doi.org/10.1007/s00192-022-05275-6