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Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication

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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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Authors and Affiliations

  1. University of Lille, Department of Urology, CHU Lille, F-59000, Lille, France

    Marie-Liesse de Guerry, Amélie Demeestere & Xavier Biardeau

  2. Department of Urology, CHU Nantes, Université de Nantes, Nantes, France

    Christophe Bergot & Marie-Aimée Perrouin-Verbe

  3. Department of Urology, CHU Bordeaux, Université de Bordeaux, Bordeaux, France

    Astrid de Hauteclocque & Grégoire Capon

  4. Department of Urology, CHU Rennes, Université de Rennes, Rennes, France

    Juliette Hascoet & Benoît Peyronnet

  5. Department of Urology, CHU Rangueil, Université Paul Sabatier Toulouse III, Toulouse, France

    Anne-Sophie Bajeot & Xavier Gamé

  6. Department of Biostatistics, CHU Lille, 59000, Lille, France

    Camille Ternynck

  7. University of Lille, Inserm UMR-S1172 LilNCog, Lille Neuroscience and Cognition, CHU Lille, FHU Precise, 59000, Lille, France

    Xavier Biardeau

  8. University of Lille, Department of Urology, Lille University Hospital, 1 rue Polonovski, 59037, Lille Cedex, France

    Xavier Biardeau

Authors
  1. Marie-Liesse de Guerry
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  2. Amélie Demeestere
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Contributions

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

Corresponding author

Correspondence to Xavier Biardeau.

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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

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