Outcome Measures of Adjustable Transobturator Male System with Pre-attached Scrotal Port for Male Stress Urinary Incontinence After Radical Prostatectomy: A Prospective Study

• Published in: Advances in therapy Vol. 34; no. 5; pp. 1173 - 1183
• Main Authors: Angulo, Javier C., Arance, Ignacio, Esquinas, Cristina, Dorado, Juan F., Marcelino, João P., Martins, Francisco E.
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.05.2017
• Subjects: Adult; Aged; Aged, 80 and over; Cardiology; Endocrinology; Health technology assessment; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Research; Pharmacology/Toxicology; Prospective Studies; Prostatectomy - methods; Prosthesis Design; Rheumatology; Suburethral Slings; Treatment Outcome; Urinary Incontinence, Stress - surgery; Adjustability; Male incontinence; Sphincter cushion; Adjustable transobturator male system (ATOMS); Radical prostatectomy; Urology
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-017-0528-5

Introduction 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. Methods 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. Results 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). Conclusion 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.