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Initial experience with ACT™ periurethral adjustable balloons to treat urinary incontinence due to intrinsic sphincter deficiency in the pediatric population

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Abstract

Purpose

To present our initial experience with periurethral adjustable continence therapy (ACT™) for urinary incontinence due to intrinsic sphincter deficiency (ISD) in children.

Methods

This is an approved prospective non-randomized pilot study (NCT03351634) aiming to treat children born with spinal dysraphism (SD) or exstrophy epispadias complex (EEC) with ACT™. Endpoints were patient-reported changes in daily pad count, 24-h Pad test and complications.

Results

Since April 2018, 13 children (six girls, seven boys) were implanted at the median age of 12 years (5–16). The etiology of incontinence was neurogenic ISD (7/13, 54%) and EEC (6/13, 46%).

After ACT™ implantation, continence (no pad or 1 security pad/day) was achieved in 9(69%) patients (5/7 SD, 4/6 EEC). Additionally, two (15%) patients had a significant improvement (decreasing Pad test from 1049 to 310 g at 3 months). One patient (7%) had no improvement. Results were stable at 21 months (6–43) of follow-up. Mean final balloon volume was 2.89 ml (± 0.85) with a median of 3 fillings to obtain continence.

We had four revisions due to cutaneous port erosion (n = 3) and balloon migration (n = 1) and two definitive explantations. PinQ score was significantly improved (47 vs 40.5 with balloon, p = ns). Neither degradation of the upper urinary tract nor cystomanometric changes have been observed at 6 and 12 months postoperatively.

Conclusion

Urinary incontinence due to ISD owing to EEC or SD can be successfully treated with ACT™ periurethral balloons. Given the minimal invasiveness of this therapy, it might be a first‐line option treatment in children with complex stress urinary incontinence.

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Data Availability

Raw data are available through the clinical research direction of Marseille Public University Hospitals (APHM) who was the study instigator.

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Acknowledgements

We wish to thank Timothy C. Cook who provided ten implantable devices units free of charge

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Authors and Affiliations

  1. APHM, Department of Pediatric Urology, CHU Timone Enfants, Marseille, France

    Alice Faure, Mirna Haddad, Jessica Pinol, Thierry Merrot & Jean-Michel Guys

  2. APHM, Department of Adult Urology and Kidney Transplantation, CHU La Conception, Marseille, France

    Floriane Michel & Gilles Karsenty

  3. Medicine Faculty, Aix-Marseille University, Marseille, France

    Alice Faure, Jessica Pinol, Thierry Merrot, Jean-Michel Guys, Floriane Michel & Gilles Karsenty

Authors
  1. Alice Faure
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  2. Mirna Haddad
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  5. Jean-Michel Guys
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Contributions

AF and GK designed the study and data collection tools, collected data for the study, wrote the statistical analysis plan, cleaned and analyzed the data, and drafted and revised the paper. MH collected data. JP, TM, JMG and FM revised the paper.

Corresponding author

Correspondence to Alice Faure.

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Conflict of interest

AF, MH, JP, TM, JMG, FM declare that they have no conflicts of interest. GK has been proctor for Uromedica ACT/proACT and is investigator in an adult female ACT study supported by Uromedica.

Research involving human participants

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (2016-AO1974-47) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was registered on ClinicalTrials.gov, and the registration number was NCT03351634.

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Informed consent was submitted for each patient.

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Faure, A., Haddad, M., Pinol, J. et al. Initial experience with ACT™ periurethral adjustable balloons to treat urinary incontinence due to intrinsic sphincter deficiency in the pediatric population. World J Urol 41, 2767–2774 (2023). https://doi.org/10.1007/s00345-023-04550-5

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