Literature DB >> 33770228

Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology.

Pierre-Luc Dequirez1, Xavier Biardeau2.   

Abstract

INTRODUCTION AND HYPOTHESIS: Using similar methodologies and outcome measures is crucial to allow pertinent literature reviews and meta-analyses. Therefore, this scoping review aims to compare methodologies of randomized clinical trials (RCTs) assessing the efficacy of third-line therapies to treat non-neurogenic OAB: intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS).
METHODS: A literature search was conducted using the PubMed search database. Using filters, the search was limited to RCTs conducted on humans and written in English or French since 2000 which evaluated BoNTA injections, SNM and/or PTNS. RCTs focusing on pediatric or neurogenic OAB were excluded. For each included RCT, methodology was assessed using a standardized form investigating the study design, clinical outcomes and urodynamic outcomes. Inclusion criteria, sex ratio, blinding strategies, treatment arms, primary outcomes and delays for reevaluation were assessed. Availability of clinical and urodynamic outcomes was reported at baseline, 3 months and 6 months.
RESULTS: Thirty-one RCTs were included in the final synthesis. The most frequent main outcome measure was change in the number of urinary incontinence episodes in 35.5% and in the number of voids per day in 25.8%. Bladder diaries were lacking in 12.9%, 32.3% and 80.1% at baseline, 3 and 6 months, respectively, while 26% of studies reported the results of urodynamic studies at any point.
CONCLUSION: Heterogeneity in study designs and data collection was pointed out between RCTs assessing the efficacy of third-line therapies to treat non-neurogenic OAB. We therefore advocate for the development of specific research guidelines focusing on OAB-related therapies.
© 2021. The International Urogynecological Association.

Entities:  

Keywords:  Onabotulinum toxin; Overactive bladder syndrome; Posterior tibial nerve stimulation; Sacral neuromodulation; Urge incontinence

Mesh:

Year:  2021        PMID: 33770228     DOI: 10.1007/s00192-021-04688-z

Source DB:  PubMed          Journal:  Int Urogynecol J        ISSN: 0937-3462            Impact factor:   2.894


  38 in total

Review 1.  The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society.

Authors:  Paul Abrams; Linda Cardozo; Magnus Fall; Derek Griffiths; Peter Rosier; Ulf Ulmsten; Philip Van Kerrebroeck; Arne Victor; Alan Wein
Journal:  Urology       Date:  2003-01       Impact factor: 2.649

2.  Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study.

Authors:  Pierre Denys; Loïc Le Normand; Idir Ghout; Pierre Costa; Emmanuel Chartier-Kastler; Philippe Grise; Jean-François Hermieu; Gérard Amarenco; Gilles Karsenty; Christian Saussine; Frédéric Barbot
Journal:  Eur Urol       Date:  2011-10-25       Impact factor: 20.096

3.  Role of botulinum toxin-A in refractory idiopathic overactive bladder patients without detrusor overactivity.

Authors:  Prashanth Kanagarajah; Rajinikanth Ayyathurai; Daniel J Caruso; Christopher Gomez; Angelo E Gousse
Journal:  Int Urol Nephrol       Date:  2011-06-04       Impact factor: 2.370

Review 4.  Management of Idiopathic Overactive Bladder Syndrome: What Is the Optimal Strategy After Failure of Conservative Treatment?

Authors:  Tom Marcelissen; Jean-Nicolas Cornu; Tiago Antunes-Lopes; Bogdan Geavlete; Nicolas Barry Delongchamps; Tina Rashid; Malte Rieken; Mohammad Sajjad Rahnama'i
Journal:  Eur Urol Focus       Date:  2018-05-26

5.  OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.

Authors:  Victor W Nitti; Roger Dmochowski; Sender Herschorn; Peter Sand; Catherine Thompson; Christopher Nardo; Xiaohong Yan; Cornelia Haag-Molkenteller
Journal:  J Urol       Date:  2016-12-22       Impact factor: 7.450

6.  The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial.

Authors:  Sender Herschorn; Alfred Kohan; Philip Aliotta; Kurt McCammon; Rajagopalan Sriram; Steven Abrams; Wayne Lam; Karel Everaert
Journal:  J Urol       Date:  2017-02-01       Impact factor: 7.450

7.  OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.

Authors:  Christopher Chapple; Karl-Dietrich Sievert; Scott MacDiarmid; Vik Khullar; Piotr Radziszewski; Christopher Nardo; Catherine Thompson; Jihao Zhou; Cornelia Haag-Molkenteller
Journal:  Eur Urol       Date:  2013-04-10       Impact factor: 20.096

8.  Prospective randomized trial of 100u vs 200u botox in the treatment of idiopathic overactive bladder.

Authors:  Waleed Altaweel; Alaa Mokhtar; Danny M Rabah
Journal:  Urol Ann       Date:  2011-05

9.  Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement.

Authors:  David Moher; Larissa Shamseer; Mike Clarke; Davina Ghersi; Alessandro Liberati; Mark Petticrew; Paul Shekelle; Lesley A Stewart
Journal:  Syst Rev       Date:  2015-01-01

10.  OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis).

Authors:  Osamu Yokoyama; Masashi Honda; Tomonori Yamanishi; Yuki Sekiguchi; Kenji Fujii; Takashi Nakayama; Takao Mogi
Journal:  Int J Urol       Date:  2020-01-20       Impact factor: 3.369

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