An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction

Abstract

Study design:To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data.Methods:A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology.Results:A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in <10% of studies; none used symptom scores validated in SCI; <50% reported urodynamic test methodology fully, incorporated urinary diaries or used International Continence Society Standardization Subcommittee urinary tract terminology.Conclusion:Integrative review of trials from 1946 to 2015 identified infrequent use of standardized clinical evaluation tools and reporting measures. Data from future trials evaluating therapies for neurogenic bladder would likely be more applicable to specific SCI patients if current standardized classification and descriptors now available were used consistently: for example, the ASIA scale, symptom scores validated in SCI, standardized urodynamic methodology, urinary diaries and urinary tract terminology. Studies recruiting SCI patients exclusively would also provide additional benefit.

Effects of a new β3‐adrenoceptor agonist, vibegron, on neurogenic bladder dysfunction and remodeling in mice with spinal cord injury

“…Because DO is one of the major problems in SCI patients, which causes urinary incontinence associated with high intravesical pressure, the improvement of NVC in the SCI mouse model suggests that vibegron treatment could reduce DO-induced urinary incontinence and high intravesical pressure, which is a risk factor for upper urinary tract dysfunctions in SCI. 3 The expression of high levels of β3-adrenoceptors in the human urinary bladder and the demonstration that activation of these receptors relaxes bladder smooth muscle has led to the development and use of selective β3-adrenoceptor agonizts to treat overactive bladder symptoms. 14 While these agents act directly to suppress bladder smooth activity, it is also possible that they have additional mechanisms of action that contribute to their clinical efficacy including inhibition of acetylcholine release from the parasympathetic nerves and suppression of bladder afferent nerve activity.…”

“…Neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI) is characterized by detrusor overactivity (DO), low bladder compliance, and detrusor‐sphincter dyssynergia (DSD) 1,2 . Clean intermittent self‐catheterization (CIC) and pharmacotherapies, such as anticholinergic agents, are recommended as the first‐line treatment to maintain a low‐pressure condition in the bladder of SCI patients with the risk of upper urinary tract damage 3 . However, anticholinergic medication is not always effective, and often causes adverse events, including dry mouth and constipation.…”

Clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury

“…Anticholinergic drugs inhibit involuntary detrusor contraction and abnormal detrusor tonus, leading to increased bladder capacity, suppressed DO and improved bladder compliance, which achieves a low‐pressure reservoir, and to control urinary incontinence . This low‐pressure storage resolves or reduces VUR and upper urinary tract dilatation, prevents renal impairment, prolongs the interval between catheterizations, and improves urinary incontinence.…”

Solifenacin in the Practice of Treating a Hyper Reflector Neurogenic Bladder

“…Беззаперечно важливим є приєднання вторинних ускладнень у формі інфекційно-запального процесу у сечостатевих шляхах (цистит, простатит, уретрит), що характеризуються низькою антибактеріальною активністю слизової оболонки. Саме тому наявність мимовільних скорочень детрузора (імперативні поклики до мікції), формування хронічної ретенції сечі (залишкова сеча) та феномен зворотного -клінічні (оцінювання чутливості в сакральних сегментах, анального і бульбокавернозного рефлексів, що замикаються на S5 і L5-S5 рівнях відповідно; проведення клінічного оцінювання розладів сечовипускання за допомогою шкал і таблиць -щоденник сечовипускань, шкали IPSS, QOL та уродинамічних досліджень) [24,25];…”