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Randomized Controlled Trial
. 2021 Sep;44(5):757-764.
doi: 10.1080/10790268.2020.1712892. Epub 2020 Jan 31.

A single-blind randomized control trial of trigonal versus nontrigonal Botulinum toxin-A injections for patients with urinary incontinence and poor bladder compliance secondary to spinal cord injury

Hui Chen  1   2 , Keji Xie  3 , Chonghe Jiang  2
Affiliations
Randomized Controlled Trial

A single-blind randomized control trial of trigonal versus nontrigonal Botulinum toxin-A injections for patients with urinary incontinence and poor bladder compliance secondary to spinal cord injury

Hui Chen et al. J Spinal Cord Med. 2021 Sep.

Abstract

Objective: To evaluate the effect of trigonal Botulinum toxin-A (BTX-A) injections on patients with urinary incontinence (UI) and poor bladder compliance (BC) secondary to spinal cord injury (SCI).Design: A single-blind randomized control trial.Setting: Department of urology in three hospitals.Participants: SCI patients with UI and poor BC were randomly assigned to either the experimental group or the control group.Interventions: The experimental group received an injection of 240 U BTX-A into the detrusor plus 60 U BTX-A into the trigone, while the control group received 300 U BTX-A into the detrusor sparing the trigone.Outcome Measures: Video urodynamic outcomes, including vesicoureteric reflux (VUR), detrusor leak point pressure (DLPP), and detrusor leak point volume (DLPV), were measured at baseline and week 12. UI episodes, voiding volume, and Incontinence Quality of Life (I-QoL) were assessed at baseline, week 2, 4, 8 and 12.Results: No patient reported new-onset VUR. Compared with baseline data, a significant improvement was achieved in both groups, whereas compared with DLPP and DLPV, a significant difference was noted between the two groups 12 weeks after injection. In the experimental group, the improvement of mean weekly UI episodes, voiding volume, and I-QoL were significantly better than those in the control group at 4, 8, and 12 weeks, respectively (all P < 0.05). Systemic complications of BTX-A injection were not reported.Conclusion: Trigonal BTX-A injection is more effective and safer than nontrigonal BTX-A injection for SCI patients with UI secondary to neurogenic-poor BC and does not result in VUR.

Keywords: Bladder trigone; Botulinum toxin-A; Poor bladder compliance; Randomized controlled trial; Spinal cord injury.

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Figures

Figure 1
Figure 1
Flow chart shows screening, randomization, treatment, and follow-up of the study. Note: a240 U BTX-A intradetrusor plus 60 U BTX-A intratrigonal injections; b300 U BTX-A intradetrusor injections.
Figure 2
Figure 2
Distribution of BTX-A injection sites. A:240U into the detrusor plus 60U into the trigone; B:300U of BTX-A into the detrusor sparing the trigone.
Figure 3
Figure 3
An example of video urodynamic output before and after BTX-A injection: (A and B) video urodynamic profile of a 34-year-old male SCI patient with sustained elevated storage pressures at baseline. (C and D) Urodynamic profile after BTX-A injection showing improvement in DLPP (57 cm H2O to 36 cm H2O) and DLPV(220 to 409 ml) in the same patient.
Figure 4
Figure 4
Reduction in weekly urinary incontinence episodes(UI) compared to baseline.
Figure 5
Figure 5
Increment in voiding volume compared to baseline.
Figure 6
Figure 6
Improvement in I-QoL compared to baseline.
See this image and copyright information in PMC

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