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Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

ABSTRACT: Sacral 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.This 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.It 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.http://www.clinicaltrials.gov; Identifier: NCT02165774.

SUBMITTER: Knupfer SC

PROVIDER: S-EPMC4139491 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

Knüpfer Stephanie C SC Liechti Martina D MD Liechti Martina D MD Mordasini Livio L Abt Dominik D Engeler Daniel S DS Wöllner Jens J Pannek Jürgen J Kiss Bernhard B Burkhard Fiona C FC Schneider Marc P MP Miramontes Elena E Kessels Alfons G AG Bachmann Lucas M LM Kessler Thomas M TM

BMC urology 20140813

<h4>Background</h4>Sacral 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.<h4>Methods and design</h4> ...[more]

PMID: 25123172

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Project description:IntroductionSacral neuromodulation (SNM) has been used in carefully selected patients with neurogenic lower urinary tract dysfunctions (nLUTD) for over two decades.MethodsThe aim of the current work was to perform a systematic literature review and meta-analysis of studies reporting the safety and effectiveness of SNM in patients with nLUTD (neurogenic detrusor overactivity, non-obstructive urinary retention, or a combination of both). For this purpose a systematic literature research was conducted using Embase (OvidSP), MEDLINE (OvidSP), MEDLINE In-Process Citations & Daily Update (OvidSP), MEDLINE (OvidSP) e-Pub ahead of print, Cochrane Central Register of Controlled Trials (CENTRAL), NIH Clinicaltrials.gov, and WHO International Clinical Trials Registry Platform (ICTRP) between 1998 and March 2020, supplemented by a hand search.ResultsForty-seven studies were included in the systematic literature review. Twenty-one studies comprising a total of 887 patients were included in the meta-analysis of test SNM. The pooled success rate of SNM test stimulation was 66.2% (95% CI 56.9-74.4). Depending on neurogenic conditions test success rates varied greatly. Twenty-four studies with a total of 428 patients were included in the meta-analysis of permanent SNM. The success rate of pooled permanent SNM was 84.2% (95% CI 77.8-89.0). Among the identified studies, the most common adverse events (AEs) were loss of effectiveness, infection, pain at implant site, and lead migration with AE rates of 4.7%, 3.6%, 3.2%, and 3.2%, respectively. Limitations entail lower level of evidence (Oxford classification 3-4) of included studies, significant risk of bias, small sample sizes in some studies, the inclusion of retrospective case series, substantial between-study heterogeneity, heterogeneous patient populations, insufficient disease classification, and variations in terms of outcome parameters as well as techniques. Furthermore, long-term data are limited.ConclusionThis meta-analysis supports not only the benefits of permanent SNM for various nLUTDs but also high overall success rates, similar to idiopathic patients. Current data of the analyzed studies showed that SNM is safe for these patients. However, more vigorous studies and/or registries are needed before definitive conclusions can be drawn.

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

Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

Publications

Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.

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