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Effect of botulinum neurotoxin A bladder injection on markers associated with inflammation and urinary infections: a human study

Effect of botulinum neurotoxin A bladder injection on markers associated with inflammation and urinary infections in patients with overactive bladder: a pilot, prospective, human study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001415594
Enrollment
28
Registered
2024-12-02
Start date
2021-03-26
Completion date
2021-11-22
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

As associations between UTIs, chronic inflammation and bladder overactivity are acknowledged, but not yet elucidated, we conducted a study to explore whether intradetrusor BoNT/A injections affect the background for increased incidence of UTIs. As Toll-like receptors (TLRs) can detect pathogens in the urinary tract, we studied the expression of TLR2, TLR4 and TLR5 in the urine of patients before and after intradetrusor BoNT/A injections. We also explored the expression of inflammatory cytokines IL-1ß, IL-6, TNFa, as well as PGE 2 , which play a significant role as intermediates of immune response and as promoters of inflammatory reactions, in the urine of patients before and after an intradetrusor BoNT/A injection. The hypothesis is that intradetrusor BoNT/A injections may alter immune and inflammatory responses in the bladder. Specifically, BoNT/A might modulate the expression of Toll-like receptors (TLR2, TLR4, TLR5) and inflammatory cytokines (IL-1ß, IL-6, TNFa, and PGE2), which play key roles promoting inflammation.

Interventions

Patients with neurogenic detrusor overactivity (NDO) associated incontinence refractory to oral pharmacotherapy who received bladder BonT/A injections were recruited. The participants would receive BonT/A treatment regardless of their involvement in this study, as a third line treatment for refractory NDO. As per routine protocol approved by the Hospital Scientific Board all patients were submitted to urodynamic investigation at baseline, 4-6 weeks and 6 months post BoNT/A treatment. Urine speci

Patients with neurogenic detrusor overactivity (NDO) associated incontinence refractory to oral pharmacotherapy who received bladder BonT/A injections were recruited. The participants would receive BonT/A treatment regardless of their involvement in this study, as a third line treatment for refractory NDO. As per routine protocol approved by the Hospital Scientific Board all patients were submitted to urodynamic investigation at baseline, 4-6 weeks and 6 months post BoNT/A treatment. Urine specimens were obtained at baseline during the cystoscopy for the BoNT/A treatment, and upon routine urodynamic follow-up visits at 4-6 weeks and at 6 months post treatment.

Sponsors

Aristotle University of Thessaloniki
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with overactive bladder symptoms / detrusor overactivity of over 1 year in duration that have received oral treatment for at least 6 months, without sufficient response, as this is defined by their reported symptoms, by bladder diary information and by urodynamic study results. Also, patients with overactive bladder symptoms / detrusor overactivity of over 1 year in duration that have severe adverse reactions to oral pharmacotherapy.

Exclusion criteria

Pregnancy and breastfeeding, neuromuscular junction disorders (e.g. myasthenia), treatment with drugs that can potentially affect neuromuscular junction (e.g. aminoglycosides), patients not willing to perform intermittent self-catheterisations.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026