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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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    Safety summary

    De novo UTI

    New UTIs, which resolved with medical treatment, were reported in 5% (3/62) of patients at 1-month follow up in the RCT. It is not clear whether they were in the treatment or placebo group (Jiang 2016).

    A UTI developed in 3 patients (with a history of recurrent UTI) in the case series of 10 patients (Panicker 2016).

    Urge urinary incontinence

    Urge urinary incontinence, which resolved with medical treatment, was reported in 5% (3/62) of patients at 1-month follow up in the RCT. It is not clear whether they were in the treatment or placebo group (Jiang 2016).

    Micturition pain

    Pain during micturition, which resolved with medical treatment, was reported in 3% (2/62) of patients at 1-month follow up in the RCT. It is not clear whether they were in the treatment or placebo group (Jiang 2016).

    Difficulty in urination (mild and resolved within 3 days after treatment) was reported in 9% (7/81) of patients in the case series of 81 patients (Jiang 2021).

    Haematuria

    Haematuria, which resolved with medical treatment, was reported in 3% (2/62) of patients at 1-month follow up in the RCT (Jiang 2016).

    Haematuria (mild and resolved in 3 days) was reported in 6% (5/81) of patients in the case series of 81 patients (Jiang 2021).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

    For this procedure, professional experts listed the following anecdotal adverse events: discomfort during the procedure and a degree of oozing of blood. They did not describe any theoretical adverse events.