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    Interventional procedure overview of botulinum toxin type A injection into the urethral sphincter for idiopathic chronic non-obstructive urinary retention

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    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/follow up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    DasGupta R. Fowler CJ. (2003) The management of female voiding dysfunction: Fowler's syndrome - a contemporary update. Current opinion in urology. 13 (4):293–299.

    Review

    Botox, sacral nerve simulation has shown some efficacy in the treatment of young women with urinary retention. Although how it works is still not fully understood but is being addressed by ongoing research.

    Review

    Fenner A (2015) Botox injections are effective for Fowler's syndrome. Nature Reviews Urology 12, 653;

    Research highlights of a pilot study

    On botulinum improves patient-reported lower urinary tract symptoms and objective measures of bladder function in women with Fowler's syndrome, according to data published.

    Review

    Jiang YH, Chen SF, Jhang JF et al. (2018) Therapeutic effect of urethral sphincter on a botulinum toxin A injection for urethral sphincter hyperactivity. Neuro-urology and Urodynamics. 37:2651–2657.

    Retrospective case series

    N=95 patients with voiding dysfunction (idiopathic voiding dysfunction n=38) due to urethral sphincter hyperactivity and treated with injections of 100 U on a botulinum toxin A into the urethral sphincter.

    1 month follow-up.

    Satisfactory outcomes were reported in 58 (61.1%) patients, of these 20 were with idiopathic voiding dysfunction. Patients with non-neurogenic voiding dysfunction had a statistically significantly longer therapeutic duration than those with neurogenic voiding dysfunction (9.55 ± 4.18 versus 7.44 ± 2.91 months, P = 0.033). Increased urinary incontinence was reported in 18 patients, including 6 with stress urinary incontinence and 12 with urgency urinary incontinence.

    Outcomes not reported separately for idiopathic voiding dysfunction.

    Jiang YH, Jhang JF, Chen SF et al. (2019) Videourodynamic factors predictive of successful on a botulinum toxin A urethral sphincter injection for neurogenic or non-neurogenic detrusor underactivity. Lower Urinary Tract Symptoms.11:66–71.

    N=60 patients (27 with non-neurogenic and 33 with neurogenic DU) refractory to medical treatment had on botulinum injections into the urethral sphincter.

    Follow-up 1 month

    Treatment outcome was statistically significantly better in patients with non-neurogenic than neurogenic DU (p=0.039). The duration of the therapeutic effect was similar between patients with non-neurogenic and neurogenic DU (mean 7.37 versus. 7.69 months, respectively; P = 0.788). In all, 12 patients reported de novo urinary incontinence after urethral botulinum injection, 4 of whom developed stress urinary incontinence and 8 who had exacerbated urgency urinary incontinence. Urethral sphincter injection of on botulinum is effective in 60% of patients with DU. Careful video urodynamic interpretation of bladder neck opening enables urologists to select appropriate candidates for on botulinum treatment.

    Outcomes no reported separately for idiopathic aetiology (n=10)

    Kuo H-K. (2003) Botulinum A toxin urethral injection for the treatment of lower urinary tract dysfunction. The Journal of Urology. Vol. 170, 1908–1912.

    Prospective case series

    N=103 patients had botulinum for various types of lower urinary tract dysfunction (DSD in 29, DV in 20, nonrelaxing urethral sphincter in 19, cauda equina lesion in 8, peripheral neuropathy in 14 and idiopathic DU in 13)

    Botulinum 50 units in 48 patients and 100 units in 55 patients.

    Follow-up 1 month.

    40 (39%) patients had an excellent result and 47 (46%) had statistically significant improvement. The total success rate was 84.5%. Among these patients mean maximum voiding pressure, MUCP and post-void residual decreased statistically significantly at 2 to 4 weeks after treatment. Among 45 patients with urinary retention the indwelling catheters were removed or clean intermittent catheterization was discontinued in 39 (87%).

    Different aetiologies were included and overall therapeutic results were presented. These patients might have been included in the studies (Kuo 2007) added to the summary of evidence.

    Kuo HC. Effectiveness of urethral injection of botulinum A toxin in the treatment of voiding dysfunction after radical hysterectomy. Urol Int 2005; 75: 247–51

    N=30 patients with difficult urination after radical hysterectomy due to cervical cancer received urethral injection of 100 units of botulinum (n = 20) or medical treatment (n = 10)

    Urethral injection of botulinum can be effectively used to treat patients with DU and non-relaxing urethral sphincter after radical hysterectomy with few adverse effects.

    Not sure if this is idiopathic as occurred after hysterectomy.

    Kao Y-L, Huang K-H, Kuo H-C et al. (2019) The therapeutic effects and pathophysiology of botulinum toxin A on voiding dysfunction due to urethral sphincter dysfunction. Toxins, 11, 728, 1-17.

    Review

    Botulinum has been applied to various causes of USD, including DV, Fowler's syndrome, and poor relaxation of the external urethral sphincter. A large proportion of patients with different causes of USD report statistically significant improvement in voiding after sphincteric botulinum injections. Botulinum is still a reasonable option for refractory voiding function. To date, studies focusing on urethral sphincter botulinum injections have been limited to the heterogeneous aetiologies of USD.

    Review

    Osman NI. & Chapple CR (2014) Fowler's syndrome—a cause of unexplained urinary retention in young women? Nature Reviews. Urology. 11, 87–98.

    Review

    Most studies of Fowler's syndrome are limited due to small cohorts with no control group and a lack of video urodynamic data. Whether Fowler's syndrome represents a distinct cause of urinary retention or results from a maladaptive behaviour and is similar to DV is unclear. Application of sacral neuromodulation in patients diagnosed with Fowler's syndrome can restore normal voiding, in the absence of any effective pharmacotherapy or surgical treatment.

    Review

    Smith CP, Nishiguchi J, O'Leary M, Yoshimura N, Chancellor MB. Single-institution experience in 110 patients with botulinum toxin A injection into bladder or urethra. Urology 2005; 65: 37–41

    N=110 received injections of BTX-A into the bladder (n = 42) or urethra (n = 68) for a variety of lower urinary tract disorders (included neurogenic detrusor overactivity and/or DSD, overactive bladder, bladder neck obstruction, and interstitial cystitis) treated with either 100 to 200 U of BTX-A IN external sphincter or by injection into the bladder base using 100 to 300 U of BTX-A diluted in about 10 to 30 mL of sterile saline.

    TX-A is equally effective in women as it is in men. When injected into the sphincter, the risk of stress incontinence is low. Bladder injections with BTX-A are effective for not only neurogenic detrusor overactivity, but also overactive bladder. BTX-A can even be considered for interstitial cystitis

    Various aetiologies (neurogenic and non-neurogenic) included.