The objective of this study was to report outcome measures with third-generation pre-attached scrotal port adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI) after radical prostatectomy.
A prospective open study was conducted on consecutive patients. Evaluation included cough test, urethroscopy, filling and voiding cystometry, 24-h pad count and pad test, patient-reported outcomes (ICIQ-SF, IIQ-7, PGI, GRA, and VAS), complications according to the Clavien–Dindo system, operative results, number of adjustments, and filling of the system.
Thirty-four patients with median pad test 510 (170–1225) ml were operated on. Preoperative SUI was mild (5.9%), moderate (17.6%), and severe (76.5%). At median 18.5 (12–26) months follow-up distribution of SUI was none (85.3%), mild (8.8%), and moderate (5.9%). Median intraoperative filling was 14 (8–17) ml, number of adjustments 1 (0–5), and total filling 17.5 (11–33.5) ml. At 3 months, median ICIQ-SF (p = 0.0001) and IIQ-7 (p < 0.0001) decreased. At 12 months, 24-h pad count and pad test decreased (both p < 0.0001), residual volume slightly increased (p = 0.018), PGI-I was 1 (1–3), GRA 6 (3–6), and 97% were satisfied with treatment. Continence (p = 0.016) and satisfaction (p = 0.09) were worse in irradiated patients. Median operative time was 67 (35–120) min, hospital stay 1 (1–3) days, and VAS for pain on postoperative day 1 was 0 (0–2). Complications presented in 14.7% (8.8% grade I and 5.9% grade III).
Treatment of severe male SUI after radical prostatectomy with pre-attached scrotal port ATOMS is safe and very effective in the short term. A positive cough test before implant and intraoperative overfilling of the system may optimize patient selection and results.
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This study has been partly presented at the EAU 2017 Meeting in London (in the session “Complications and functional outcomes after radical prostatectomy”). No funding or sponsorship was received for this study or publication of this article. The article processing charges were funded by the authors. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. The authors acknowledge José Domínguez for iconography.
Javier C. Angulo, Ignacio Arance, Cristina Esquinas, Juan F. Dorado, João P. Marcelino, and Francisco E. Martins declare that they have no personal, financial, commercial, or academic conflicts of interest regarding the publication of this article.
Compliance with Ethics Guidelines
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.
The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.
JCA: protocol/project development. IA, CE, and JPM: data collection or management. JFD: data analysis. JCA and FEM: manuscript writing/editing.
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Angulo, J.C., Arance, I., Esquinas, C. et al. Outcome Measures of Adjustable Transobturator Male System with Pre-attached Scrotal Port for Male Stress Urinary Incontinence After Radical Prostatectomy: A Prospective Study. Adv Ther 34, 1173–1183 (2017). https://doi.org/10.1007/s12325-017-0528-5
- Adjustable transobturator male system (ATOMS)
- Male incontinence
- Radical prostatectomy
- Sphincter cushion