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 OJU  Vol.3 No.2 , May 2013
Five Years Follow-Up of Adjustable Continence Therapy (ACT) in the Treatment of Recurrent Female SUI
Abstract: Purpose/Objective: The primary objective of this FDA study is to evaluate the safety and efficacy of the ACT device (Adjustable Continence Therapy) in the treatment of female recurrent Stress Urinary Incontinence (SUI). The secondary objective is to evaluate the difficulty of placement and aspects of device adjustability. Materials and Methods: The Adjustable Continence Therapy (ACT) system (Uromedica, Inc., Plymouth, MN) consists of two silicone balloons providing urethral coaption and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative adjustment of volume. Females with recurrent SUI with or without urethral hypermobility were evaluated at baseline and follow-up periods of 6 weeks, 3, 6, 9, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test, direct visual stress test, Stamey score and validated questionnaires to assess severity of incontinence, voiding dysfunction, sexual function and quality of life. Results: During a 5 years period (2002-2007), 162 patients were implanted (mean age 67.6, range 31 - 94 years). Of these 162 patients 142, 90, 80, 56 and 31 patients completed the 1, 2, 3, 4 and 5 years follow-up respectively. One hundred and thirty five (83%) had failed at least one surgery for incontinence and 44% had failed 2 or more procedures prior to ACT implantation. Difficulty of ACT placement was rated mild in 62%, moderate in 30% and severe in 9%. Improvement in Stamey score of >1 grade was achieved in 75% (107/142) at 1 year, 76% (68/90) at 2 years, 86% (62/78) at 3 years, 93% (50/54) at 4 years and 83% (25/30) at 5 years. Dry rate (provocative pad weight < 2 gms) was 51%, 62% , 76%, 76% and 76% at 1 through 5 years, and >50% improvement was achieved in 83%, 86%, 86%, 90% and 93%,respectively. IQoL improved from 37 at baseline to 71, 71, 75, 77 and 74 during the study, and optimal continence was achieved with a mean of 4 adjustments, and mean balloon volumes of 4.0 ml (1.0 - 11.5 ml). Complications including bladder perforation, erosion, migration, pain and urinary retention were reported in 25% (38/155) at 12 months, and 9% (10/109), 3% (3/91) , 6% (5/79) and 4% (3/69) respectively, and of these, the majority were mild to moderate. At 5 years, 33 patients had undergone permanent explants of both devices, 48 were lost to follow-up and 6 had died of unrelated causes. Conclusions: Five years data suggest that ACT is, a safe and effective, minimally invasive treatment for recurrent SUI, which is easy to place and adjust to optimize urinary control without impairing bladder emptying.
Cite this paper: N. Galloway, S. Aboseif, P. Sassani, E. Franke, S. Nash, J. Slutsky, M. Tu, P. Pommerville, N. Baum and S. Sutherland, "Five Years Follow-Up of Adjustable Continence Therapy (ACT) in the Treatment of Recurrent Female SUI," Open Journal of Urology, Vol. 3 No. 2, 2013, pp. 132-137. doi: 10.4236/oju.2013.32025.
References

[1]   P. Abrams, L. Cardozo, M. Fall, et al., “The Standardization of Terminology of the Lower Urinary Tract Function: Report from the Standardization Sub-Committee of the International Continence Society,” Neurourology and Urodynamics, Vol. 21, No. 2, 2002, pp. 167-178. doi:10.1002/nau.10052

[2]   P. Sassani and S. R. Aboseif, “Stress Urinary Incontinence in Women,” Current Urology Reports, Vol. 10, No. 5, 2009, pp. 333-337. doi:10.1007/s11934-009-0052-5

[3]   E. Kocjancic, S. Crivellaro, S. Ranzoni, D. Bonvini, B. Grosseti and B. Frea, “Adjustable Continence Therapy for Severe Intrinsic Sphincter Deficiency and recurrent Female Stress Urinary Incontinence: Long-Term Experience,” The Journal of Urology, Vol. 184, No. 3, 2010, pp. 1017-1021. doi:10.1016/j.juro.2010.05.024

[4]   C. Pope, P. J. R. Shaw and M. J. Coptcoat, “Changes in Bladder Function Following a Surgical Alteration in Outflow Resistance,” Neurourology and Urodynamics, Vol. 18, 1999, p. 629.

[5]   S. Crivellaro and J. J. Smith, “Minimally Invasive Therapies for Female Stress urinary Incontinence: Current Status of Bioinjectables/New Devices (Adjustable Continence Therapy, Urethral Sub Mucosal Collagen Denaturation by Radiofrequency),” The Scientific World Journal, Vol. 9, 2009.

[6]   J. Wachter, A. Henning, M. Roehlich, et al., “Adjustable Continence Therapy for Female Urinary Incontinence: A Minimally Invasive Option for the Difficult Case,” International Journal of Urology, Vol. 81, 2008, pp. 160-166. doi:10.1159/000144054

[7]   L. Le Normand, “Les Ballonets Ajustables (ACT?) Periuretraux Pour le Traitement de l’Incontinencede la Femme,” Pelvi-Perineal, Vol. 1, 2007, pp. 1-5.

[8]   E. Chartier-Kastler, P. Costa, K. B. Naoum, F. Cour, L. Le Normand and F. Haab, “Prospective Multicenter French Study on the Use of ACT? Balloons for the Treatment of Urinary Incontinence in Women,” Progrès en Urologie, Vol. 17, No. 7, 2007, pp. 1372-1377. doi:10.1016/S1166-7087(07)78580-9

[9]   S. Kuschel and B. Schussler, “Results of Function and Safety of the Safyre-t, a Hybrid Transobturator Vaginal Sling for the Treatment of Stress Urinary Incontinence,” Neurourology and Urodynamics, Vol. 27, No. 5, 2008, pp. 403-406. doi:10.1002/nau.20528

[10]   E. David-Montefiore, J. L. Frobert, M. Grisard-Anaf, et al., “Functional Results after Sub Urethral Sling Procedure for Urinary Stress Incontinence at 1 Year: A French Prospective Multicenter Study Comparing the Retropubic and Transobturator Routs,” International Urogynecology Journal and Pelvic Floor Dysfunction, Vol. 17, Suppl. 2, 2006, p. S95.

[11]   R. M. Houwert, P. L. venema, A. E. Aquarius, et al., “Predictive Value of Urodynamics on the Outcome after Midurethral Sling Surgery for Female Stress Urinary Incontinence,” American Journal of Obstetrics and Gynecology, 2009. www.AJOG.org

[12]   P. H. Song, Y. D. Kim, H. D. Kim, et al., “The 7-Year Outcome of the Tension Free Vaginal Tape Procedure for Treating Female Stress Urinary Incontinence,” BJU International, Vol. 104, No. 8, 2009, pp. 1113-1117. doi:10.1111/j.1464-410X.2009.08504.x

[13]   M. Mittenberger, G. M. Pinggera, R. Marksteiner, et al., “Adult Stem Cell Therapy for Female Stress Urinary Incontinence,” European Urology, Vol. 53, No. 1, 2008, pp. 169-175. doi:10.1016/j.eu ruro.2007.07.026

[14]   K. E. O’Connell, S. Kalavampara, B. Frea, P. Robertson and E. Kocjancic, “Cadaveric Study of ACT Balloons and Their Impact on Female Sexual Anatomy,” Pelviperineology, Vol. 26, 2007, pp. 53-56.

[15]   A. Stecco, A. Saponaro, S. Crivellaro, C. Raffaele, A. Otroneo, B. Frea, A. Carriero and E. Kocjancic, “Can MRI Predict Which Patients Are Most Likely to Benefit from Percutaneous Positioning of Volume-Adjustable Balloon Devices?” Urologia Internationalis, Vol. 76, 2006, pp. 240-246. doi:10.1159/000091627

[16]   E. Chartier-Kastler, P. Costa, K. Ben, Naoum, et al., “French Multicenter Prospective Study of the Use of ACT Balloons for the Treatment of Female Stress Urinary Incontinence,” Progrès en Urologie, Vol. 17, No. 7, 2007, pp. 1372-1377. doi:10.1016/S1166-7087(07)78580-9

[17]   E. Kocjanacic, B. Frea, P. Robertson and H. E. O’Connell, “Anatomical Basis for Effective Placement of Adjustable Continence Therapy (ACT) Balloons for Treatment of Female Stress Urinary Incontinence,” Pelviperineology, Vol. 26, 2007, pp. 88-90.

[18]   E. Kocjancic, S. Crivellaro, J. J. Smith, et al., “Adjustable Continence Therapy for Treatment of Recurrent Female Urinary Incondinence,” Journal of Endourology, Vol. 22, No. 7, 2008, pp. 1403-1407. doi:10.1089/end.2008.0027

[19]   S. R. Aboseif, E. I. Franke, S. D. Nash, J. N. Slutsky, N. H. Baum, M. Le Tu, N. T. Galloway, P. J. Pommerville, S. E. Sutherland and J. F. Bressette, “The Adjustable Continence Therapy (ACT) System for Recurrent Female Stress Urinary Incontinence; One Year Results of the North America Clinical Study Group,” Journal of Urology, Vol. 181, No. 5, 2009, pp. 2187-2191. doi:10.1016/j.ju ro.2009.01.039

[20]   S. R. Aboseif, P. Sassani, E. I. Franke, S. D. Nash, J. N. Slutsky, N. H. Baum, M. Le Tu, N. T. Galloway, P. J. Pommerville and S. E. Sutherland, “Treatment of Moderate to Severe Female Stress Urinary Incontinence with the Adjustable Continence Therapy (ACT) Device after Failed Surgical Repair,” WJU, Vol. 29, No. 2, 2010, pp. 249-253.

[21]   A. Vidart and F. Cour, “Guidelines for the Treatment of Non-Neurological Urinary Incontinence Women Using Periurethral Balloons,” Progrès en Urologie, Vol. 20, Suppl. 2, 2010, pp. S150-S154. doi:10.1016/S1166-7087(10)70010-5

[22]   B. Vayleux, F. Luyckx, S. Thelu, J. Rigaud, O. Bouchot, G. Karam, L. Le Normand, “Resultats Fonctionnels des Ballonnets Periuretraux ACT Chez la Femme (Functional Results of Adjustable Continence Therapy in Women),” Pelvi-Perineologie,Vol. 5, No. 2, 2010, pp. 83-89. doi:10.1007/s11608-010-0304-3

[23]   B. Vayleux, F. Luyckx, S. Thelu, J. Rigaud, O. Bouchot, G. Karam, L. Le Normand, “Les Ballonets Périurétraux ACT Chez la Femme: Suivi à Moyen Terme et Aide au Positionnement,” Progrès en Urologie, Vol. 20, No. 7, 2010, pp. 420-526. doi:10.1016/j.purol.2010.01.010

[24]   E. Chartier-Kastler, P. Costa, K. B. Naoum, F. Cour, L. Le Normand and F. Haab, “Prospective Multicenter French Study on the Use of ACT Balloons for the Treatment of Urinary Incontinence in Women,” Progrès en Urologie, Vol. 17, No. 7, 2007, pp. 1372-1377. doi:10.1016/S1166-7087(07)78580-9

 
 
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