Dataset Information

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.

SUBMITTER: Stothers L

PROVIDER: S-EPMC5308214 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Stothers L L Tsang B B Nigro M M Lazare D D Macnab A A

Spinal cord 20160531 12

<h4>Study design</h4>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.<h4>Methods</h4>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 Ps ...[more]

PMID: 27241452

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Project description:BackgroundSacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials.Methods and designThis study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation.DiscussionIt is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction.Trial registrationTrial registration numberhttp://www.clinicaltrials.gov; Identifier: NCT02165774.

Project description:IntroductionNeurogenic lower urinary tract dysfunction (NLUTD) both threatens the health of affected patients long-term and also has a significantly negative impact on the patients' quality of life. present, many clinical practice guidelines (CPGs) have been developed for NLUTD patients, but these CPGs may confuse healthcare professionals and patients due to their great difference in terms of scope, quality and content. This review aims to identify the CPGs for NLUTD patients published from 2012 to 2022, assess their quality and then analyse them in an integrated manner.Methods and analysisWe will systematically search electronic healthcare databases (English databases including PubMed, EMBASE, OVID, Scopus, Web of Science, Cochrane Library, CINAHL, UpToDate, and Best Practice and Chinese databases including China National Knowledge Infrastructure, Wanfang Database, VIP Periodical Resource Integration Service Platform and SinoMed), online CPG repositories and relevant professional association websites to identify eligible CPGs. The CPGs published in English and Chinese with full texts available within the period from January 2012 to March 2022 will be included in this study. The Appraisal of Guidelines for Research and Evaluation (AGREE) II will be used to assess the quality of included CPGs. According to the predesigned data table, the general characteristics of these CPGs, proposed recommendations and their quality of evidence, strength of recommendation and other information will be extracted. Qualitative thematic analysis will be applied to the extracted recommendations. A summary of the proposed recommendations, their quality of evidence, strength of recommendation and other information will eventually be described in a table. This review is expected to identify knowledge gaps in current CPGs and to identify the areas of the proposed recommendations derived from low-level evidence. ETHICS AND DISSEMINATION : This systematic review does not involve the participation of any subjects, and therefore no ethical approval is required. The findings of this review will be published in a peer-reviewed journal and disseminated via conference presentations.Prospero registration numberCRD42022318180.

Dataset Information

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

Study design

Methods

Results

Conclusion

Publications

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

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