Abstract:
PURPOSE:The purpose of the study was to assess safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) in female subjects with predominant stress urinary incontinence. METHODS:A randomized, double-blind, multicenter trial examined intra-sphincteric injection of 150 × 106 AMDC-USR versus placebo in female subjects with stress or stress predominant, mixed urinary incontinence. AMDC-USR products were generated from vastus lateralis needle biopsies. Subjects were randomized 2:1 to receive AMDC-USR or placebo and 1:1 to receive 1 or 2 treatments (6 months after the first). Primary outcome was composite of ≥ 50% reduction in stress incontinence episode frequency (IEF), 24-h or in-office pad weight tests at 12 months. Other outcome data included validated subject-recorded questionnaires. Subjects randomized to placebo could elect to receive open-label AMDC-USR treatment after 12 months. Subject follow-up was up to 2 years. RESULTS:AMDC-USR was safe and well-tolerated with no product-related serious adverse events or discontinuations due to adverse events. Interim analysis revealed an unexpectedly high placebo response rate (90%) using the composite primary outcome which prevented assessment of treatment effect as designed and thus enrollment was halted at 61% of planned subjects. Post hoc analyses suggested that more stringent endpoints lowered placebo response rates and revealed a possible treatment effect. CONCLUSIONS:Although the primary efficacy finding was inconclusive, these results inform future trial design of AMDC-USR to identify clinically meaningful efficacy endpoints based on IEF reduction, understanding of placebo response rate, and refinement of subject selection criteria to more appropriately align with AMDC-USR's proposed mechanism of action.
journal_name
Int Urol Nephroljournal_title
International urology and nephrologyauthors
Jankowski RJ,Tu LM,Carlson C,Robert M,Carlson K,Quinlan D,Eisenhardt A,Chen M,Snyder S,Pruchnic R,Chancellor M,Dmochowski R,Kaufman MR,Carr Ldoi
10.1007/s11255-018-2005-8subject
Has Abstractpub_date
2018-12-01 00:00:00pages
2153-2165issue
12eissn
0301-1623issn
1573-2584pii
10.1007/s11255-018-2005-8journal_volume
50pub_type
杂志文章,多中心研究,随机对照试验abstract::Infertility may occur in patients with unilateral testicular torsion whose contralateral testis is intact. Depending on this observation, the physicians have begun to examine the contralateral testis. In the present prospective study we aimed to examine the histopathologic alterations occurring in the contralateral te...
journal_title:International urology and nephrology
pub_type: 杂志文章
doi:10.1007/BF02550935
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abstract::We report a case of 20-year-old farmer with penile amputation and emasculation secondary to crushing injury inflicted by agricultural machinery. His entire penis, scrotum and both the testis had been avulsed after falling onto a rotating axel wheel of an electronically driven thrashing machine. After resuscitation the...
journal_title:International urology and nephrology
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doi:10.1007/s11255-004-0918-x
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abstract::Neuron specific enolase (NSE) is an isoenzyme of the glycolytic enzyme enolase. It is not only a marker for all types of neurons but also for all neuroendocrine or paraneuronal cells and various malignant tumours, even of non-neuroendocrine types. We had studied serum NSE in 25 consecutive patients with renal cell car...
journal_title:International urology and nephrology
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doi:10.1007/BF02550862
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abstract:INTRODUCTION:Renal function after renal surgery depends on the volume of renal parenchyma loss and improves in the postoperative period. However, the knowledge on kidney function after radical (RN) and partial (PN) nephrectomy is still insufficient. The aim of this study is to analyze the global renal function and comp...
journal_title:International urology and nephrology
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abstract::A unilateral adrenal tumour was incidentally detected in a 39-year-old woman with no characteristic features of Cushing's syndrome. Basal levels of glucocorticoids were within normal limits. However, abnormal pattern of plasma cortisol and ACTH was observed. The dexamethasone suppression test and the metyrapone test s...
journal_title:International urology and nephrology
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doi:
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abstract::Chronic renal failure is a risk factor for tuberculosis. In the past five years we have identified two cases of tuberculosis in our dialysis population. The first patient, showed chronic failure to thrive on hemodialysis. An enlarged cervical lymph node was biopsied and, although no acid fast bacilli (AFB) were seen, ...
journal_title:International urology and nephrology
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abstract::In 44 patients (22 females, 22 males, aged 18-61 years, mean 36 years) regular dental screening and treatment were started in January 1982. Two years follow-up revealed that the oral hygiene of these haemodialysis patients was worse than that of the average population. In 42 cases calculus formation and gingivitis, in...
journal_title:International urology and nephrology
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abstract::The vesical stone formation due to intravesical mesh erosion of tension-free vaginal tape (TVT) is rare. In this report, a case of 48-year-old patient who underwent (TVT) elsewhere is discussed. The patient was presented with vesical stone and persistent stress urinary incontinence. Intravesical stone was detected by ...
journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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abstract:PURPOSE:In the present study we have performed a correlation of the most prevailing clinical conditions of multiple sclerosis (MS) with overall drug response and the grade of the disease. MATERIALS AND METHODS:One hundred and ten patients were consecutively and prospectively studied with a clinical syndrome of MS, ran...
journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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abstract::Low-molecular-weight heparins (LMWHs) have been widely used in many clinical settings. LMWH-associated spontaneous retroperitoneal hematoma (SRH) has been reported mostly in patients treated with enoxaparin. We here present a 76-year-old man with renal insufficiency treated with dalteparin for acute myocardial infarct...
journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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journal_title:International urology and nephrology
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