None listed
Conditions
Brief summary
Botulinum A Toxin is currently used to treat refractory urinary urgency. This research uses a part existing retrospective and part (with regard to concept)- prospectively collected dataset that is very detailed, and which documents the care of real-world treatment-seeking women in the community. Existing patient records will be used to compile a large study data set that in turn will be used to create a predictive model for Botox treatment outcome. This will be internally and if promising, externally validated, and finally, clinically trialed for its usefulness as a predictive model to guide initial and also subsequent Botox use. Additionally, any negative effects for those receiving Botox and other treatments over time such as deterioration in bladder function will be tracked. The aim is to achieve more effective, efficient treatment of storage symptoms that is relevant to real-world treatment-seeking women. Such a model does not currently exist.
Interventions
Nil intervention. Creation starting in May 2021 of an observational study dataset by the principal investigator, using as the source the details obtained from the patient files of all women receiving an initial Botulinum A toxin bladder wall injection as part of their standard care and who provided at that time, detailed standardized symptom and demographic as well as general medical and surgical history, and who allowed detailed physical examination including bladder wall visualization, urodyna
Nil intervention. Creation starting in May 2021 of an observational study dataset by the principal investigator, using as the source the details obtained from the patient files of all women receiving an initial Botulinum A toxin bladder wall injection as part of their standard care and who provided at that time, detailed standardized symptom and demographic as well as general medical and surgical history, and who allowed detailed physical examination including bladder wall visualization, urodynamic studies, imaging, urine culture before and after treatment and who were followed up for a minimum of 12 months post-treatment. The Botulinum A toxin (Botox) was for the treatment of refractory storage lower urinary tract symptoms with an urge component. The treatments started in 2002 and continue. Patients treated from 2002 to April 2021 will be included. They are followed-up at 10 days, 3 months, 12 months post Botox treatment, then further irregularly and indefinitely for as long as individuals return for care. Details of any further treatments and complications were/ will be included and further history and clinical examination details will be collected when available until 2025. The concept for this study originated in January 2016 and the patient information recorded will be influenced by this time point. The study data set will allow the creation of a predictive model for Botox treatment success and explore the specific factors associated with success. A future observational study collecting similar but only relevant existing data from a geographically separate group will be planned to externally validate the predictive model generated but only if the training model validates adequately internally
Sponsors
Jane Manning
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Botox administration is an inclusion criterion The great majority, of women, do or will have urgency. If not urgency, they will have other symptoms, history, examination findings, suggesting urge or OAB is present.. All were / will be treatment-refractory or unsuitable to have anticholinergics and some later Mirabegron, before Botox was or is considered. They are included if they have other failed therapies prior to being considered for Botox; This includes Sacral nerve stimulation, PTNS, Hydrodistension, physiotherapy, bladder neck surgery, prolapse surgery, vaginal pessary device are other treatments applied.
Exclusion criteria
Exclusions: This study uses an existing and future clinical dataset. There are 2 time points of exclusion. 1. There are study dataset exclusions from the existing and the future growing dataset. These are as follows: Those few given Botox where voiding with catheter assistance was already established will be excluded as it is considered the inclusion of this subgroup will bias by confounding the variable ‘retention’ as a valid and useful potential predictor for treatment failure after Botox. For those not already catheterizing, where retention seemed likely, Botox is and will be excluded unless the patient insists and accepts urinary retention risk- here a reduced dose was given in some cases. 2. Some community treatment seeking women were and continue to be excluded from the existing and future dataset and thus will be excluded from the proposed future study dataset. These are as follows: 2. Women have been or will be excluded from treatment when it is / was deemed clinically inappropriate. Excluded are and will be those with other discoverable and treatable underlying causes for their urge or LUT symptoms, but only where that treatment had resolved symptoms sufficiently for the patient not to request Botox subsequently. Thus, those responding well enough to other treatments such as pessaries, physiotherapy, bladder training, medications, antibiotics, posterior tibial nerve stimulation (PTNS), prolapse surgery and Sacral nerve stimulation (SNS), were not considered further for Botox treatment. Women were excluded when they did not feel symptoms were sufficiently troublesome, Botox was refused in some cases due to patient anxiety. Cost excluded many from treatment prior to 2014 when Botox was not funded and required day surgery admission and in the public system- a long delay; Prior Botox treatment was an exclusion. Those with milder urge were often exduded prior to 2014 when there was high cost and no outpatient Botox availability; This would affect the frail and poorly funded. Prior to the mesh debate of 2018 many were excluded as they preferred bladder neck surgery for mixed incontinence Those with voiding impairment together with recurrent refractory urinary tract infections (UTI) were and are more likely to be excluded over time particularly if better alternatives were available as infection risk became apparent. Once Botox became PBS listed, treatment selection followed and continues to follow Australian PBS criteria for Botox use which excludes those who do not have ‘’symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication... (and) treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by a urodynamic study, in a patient who is not adequately managed by anti-cholinergic therapy. Inadequate management by anti-cholinergic therapy is shown by an insufficient response or if the patient experiences intolerable side effects necessitating permanent withdrawal from treatment.’’ Counselling affects patient treatment choice. Patients were initially warned of a ~ 7% risk of transient voiding impairment requiring temporary catheter use and a 21% risk of bladder infection. This likely caused many to exclude themselves. These exclusions reduced with introduction of PBS funding and a standard 100U Ona-Botulinum toxin A dose,
Outcome results
None listed