Autologous Muscle-derived Cell Injection for Treatment of Female Stress Urinary Incontinence: A Single- Arm Clinical Trial with 24-months Follow-Up
Urology Journal,
Vol. 16 No. 5 (2019),
21 October 2019
,
Page 482-487
https://doi.org/10.22037/uj.v16i5.4736
Abstract
Purpose: This clinical study evaluated the effect of autologous muscle-derived cell (MDC) injection for the treatment of female patients with pure stress urinary incontinence (SUI).
Materials and Methods: A total of 20 women with SUI received transurethral injections of autologous MDCs. Baseline and follow-up evaluations consisted of physical examinations (cough stress tests), one-hour pad test, Incontinence Impact Questionnaire-7 (IIQ-7), and Urogenital Distress Inventory (UDI-6) scoring. The patients were followed one week as well as 1, 3, 6, 9, 12, and 24 month(s) after the procedure. Multichannel urodynamic study were performed before and 24 months after the intervention. The incidence and severity of adverse events (AE) were also recorded at each follow-up visit.
Results: A total of 20 eligible female patients with the chief complaint of SUI that was unresponsive to conservative management, was enrolled in the trial, 17 of whom completed all follow-up visits. At 12th months, 10 (59%) patients had complete response, whereas 2 (12%) and 5 (29%) patients had partial and no response, respectively. At 24th months, relapse of SUI in 5 out of 10 complete responders (29%) and 2 out of 2 partial responders to the treatment, respectively. The intervention produced no serious AE during the trial.
Conclusion: According to our results, though obtained from a limited number of patients, MDC therapy was a minimally invasive and safe procedure for treatment of female patients with pure SUI. However, currently, the efficacy of this type of treatment for SUI is not sufficiently high and multi-center randomized clinical trials are required to be conducted before reaching a concrete conclusion.
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References
Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003; 62: 16-23.
----------------------------------------------------------------------------
Abrams P, Cardozo L, Fall M et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003; 61: 37-49.
----------------------------------------------------------------------------
Hannestad YS, Rortveit G, Sandvik H, Hunskaar S, Norwegian EsEoIitCoN-T. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. Journal of clinical epidemiology. 2000; 53: 1150-7.
-----------------------------------------------------------------------------
Moroni RM, Magnani PS, Haddad JM, Castro Rde A, Brito LG. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia. 2016; 38: 97-111.
------------------------------------------------------------------------------
Albo ME, Richter HE, Brubaker L et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. The New England journal of medicine. 2007; 356: 2143-55.
-------------------------------------------------------------------------------
Deng DY, Rutman M, Raz S, Rodriguez LV. Presentation and management of major complications of midurethral slings: Are complications under-reported? Neurourology and urodynamics. 2007; 26: 46-52.
-------------------------------------------------------------------------------
Oberpenning F, Meng J, Yoo JJ, Atala A. De novo reconstitution of a functional mammalian urinary bladder by tissue engineering. Nature biotechnology. 1999; 17: 149-55.
-------------------------------------------------------------------------------
Mitterberger M, Pinggera GM, Marksteiner R et al. Functional and histological changes after myoblast injections in the porcine rhabdosphincter. European urology. 2007; 52: 1736-43.
-------------------------------------------------------------------------------
Sharifiaghdas F, Tajalli F, Taheri M et al. Effect of autologous muscle-derived cells in the treatment of urinary incontinence in female patients with intrinsic sphincter deficiency and epispadias: A prospective study. International journal of urology : official journal of the Japanese Urological Association. 2016; 23: 581-6.
-------------------------------------------------------------------------------
Bump RC, Mattiasson A, Bo K et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. American journal of obstetrics and gynecology. 1996; 175: 10-7.
-------------------------------------------------------------------------------
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourology and urodynamics. 1995; 14: 131-9.
-------------------------------------------------------------------------------
Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourology and urodynamics. 2002; 21: 167-78.
-------------------------------------------------------------------------------
Chancellor MB, Yokoyama T, Tirney S et al. Preliminary results of myoblast injection into the urethra and bladder wall: a possible method for the treatment of stress urinary incontinence and impaired detrusor contractility. Neurourol Urodyn. 2000; 19: 279-87.
------------------------------------------------------------------------------
Yokoyama T, Huard J, Pruchnic R et al. Muscle-derived cell transplantation and differentiation into lower urinary tract smooth muscle. Urology. 2001; 57: 826-31.
-------------------------------------------------------------------------------
Lee JY, Cannon TW, Pruchnic R, Fraser MO, Huard J, Chancellor MB. The effects of periurethral muscle-derived stem cell injection on leak point pressure in a rat model of stress urinary incontinence. International urogynecology journal and pelvic floor dysfunction. 2003; 14: 31-7; discussion 7.
-------------------------------------------------------------------------------
Kim YT, Kim DK, Jankowski RJ et al. Human muscle-derived cell injection in a rat model of stress urinary incontinence. Muscle & nerve. 2007; 36: 391-3.
-------------------------------------------------------------------------------
Carr LK, Steele D, Steele S et al. 1-year follow-up of autologous muscle-derived stem cell injection pilot study to treat stress urinary incontinence. International urogynecology journal and pelvic floor dysfunction. 2008; 19: 881-3.
------------------------------------------------------------------------------
Blaganje M, Lukanovic A. Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2012; 117: 164-7.
------------------------------------------------------------------------------
Gras S, Klarskov N, Lose G. Intraurethral injection of autologous minced skeletal muscle: a simple surgical treatment for stress urinary incontinence. The Journal of urology. 2014; 192: 850-5.
-------------------------------------------------------------------------------
Yokoyama T, Yoshimura N, Dhir R et al. Persistence and survival of autologous muscle derived cells versus bovine collagen as potential treatment of stress urinary incontinence. The Journal of urology. 2001; 165: 271-6.
-------------------------------------------------------------------------------
Badra S, Andersson KE, Dean A, Mourad S, Williams JK. Long-term structural and functional effects of autologous muscle precursor cell therapy in a nonhuman primate model of urinary sphincter deficiency. The Journal of urology. 2013; 190: 1938-45.
-------------------------------------------------------------------------------
Torrente Y, Belicchi M, Marchesi C et al. Autologous transplantation of muscle-derived CD133+ stem cells in Duchenne muscle patients. Cell transplantation. 2007; 16: 563-77.
-------------------------------------------------------------------------------
Sebe P, Doucet C, Cornu JN et al. Intrasphincteric injections of autologous muscular cells in women with refractory stress urinary incontinence: a prospective study. International urogynecology journal. 2011; 22: 183-9.
-------------------------------------------------------------------------------
Mitterberger M, Pinggera GM, Marksteiner R et al. Adult stem cell therapy of female stress urinary incontinence. European urology. 2008; 53: 169-75.
------------------------------------------------------------------------------
Stangel-Wojcikiewicz K, Jarocha D, Piwowar M et al. Autologous muscle-derived cells for the treatment of female stress urinary incontinence: a 2-year follow-up of a Polish investigation. Neurourology and urodynamics. 2014; 33: 324-30.
------------------------------------------------------------------------------
Kuismanen K, Sartoneva R, Haimi S et al. Autologous adipose stem cells in treatment of female stress urinary incontinence: results of a pilot study. Stem cells translational medicine. 2014; 3: 936-41.
------------------------------------------------------------------------------
Mitterberger M, Marksteiner R, Margreiter E et al. Autologous myoblasts and fibroblasts for female stress incontinence: a 1-year follow-up in 123 patients. BJU international. 2007; 100: 1081-5.
------------------------------------------------------------------------------
Carr LK, Robert M, Kultgen PL et al. Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study. The Journal of urology. 2013; 189: 595-601.
------------------------------------------------------------------------------
Stangel-Wojcikiewicz K, Piwowar M, Jach R, Majka M, Basta A. Quality of life assessment in female patients 2 and 4 years after muscle-derived cell transplants for stress urinary incontinence treatment. Ginekologia polska. 2016; 87: 183-9.
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