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CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Diabetes mellitus does not affect the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with refractory detrusor overactivity.
Neurourology and Urodynamics 2014 November
AIMS: To investigate the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with diabetes mellitus (DM) and refractory detrusor overactivity (DO).
METHODS: Forty-eight type 2 DM patients with refractory DO received intravesical 100 U onabotulinumtoxinA injection. Another 48 age-matched patients were randomly selected from a non-diabetic group as controls. Video-urodynamic studies were performed at baseline and were repeated 3 months after treatment. The treatment outcomes were graded on the basis of changes in the Patient's Perception of Bladder Condition (PPBC) and a PPBC decrease of 2 or more points was considered successful. Treatment-related adverse events including acute urinary retention, large post-voiding residual (PVR) volumes, straining to void, urinary tract infection, hematuria, and general weakness were recorded.
RESULTS: The mean ages of the diabetic and non-diabetic patients were 73.1 ± 8.8 and 72.0 ± 9.3 (P = 0.552), respectively. The changes of urodynamic parameters were comparable between the two groups. Similar successful results were noted at the 6-month follow-up (DM, 56% vs. non-DM, 61%, P = 0.128). Diabetic patients had a significantly greater incidence of large PVR volumes (DM, 60.4% vs. non-DM, 33.3%; P = 0.007) and general weakness (DM, 10.4% vs. non-DM, 0%; P = 0.03) after treatment. Baseline urodynamic parameters in diabetic patients did not predict the occurrence of adverse events. No major complication was noted in either group.
CONCLUSIONS: Intravesical onabotulinumtoxinA injection is a safe and effective treatment for DM patients with refractory DO. Patients with DM should be informed of the increased risk of large PVR before initiation of treatment.
METHODS: Forty-eight type 2 DM patients with refractory DO received intravesical 100 U onabotulinumtoxinA injection. Another 48 age-matched patients were randomly selected from a non-diabetic group as controls. Video-urodynamic studies were performed at baseline and were repeated 3 months after treatment. The treatment outcomes were graded on the basis of changes in the Patient's Perception of Bladder Condition (PPBC) and a PPBC decrease of 2 or more points was considered successful. Treatment-related adverse events including acute urinary retention, large post-voiding residual (PVR) volumes, straining to void, urinary tract infection, hematuria, and general weakness were recorded.
RESULTS: The mean ages of the diabetic and non-diabetic patients were 73.1 ± 8.8 and 72.0 ± 9.3 (P = 0.552), respectively. The changes of urodynamic parameters were comparable between the two groups. Similar successful results were noted at the 6-month follow-up (DM, 56% vs. non-DM, 61%, P = 0.128). Diabetic patients had a significantly greater incidence of large PVR volumes (DM, 60.4% vs. non-DM, 33.3%; P = 0.007) and general weakness (DM, 10.4% vs. non-DM, 0%; P = 0.03) after treatment. Baseline urodynamic parameters in diabetic patients did not predict the occurrence of adverse events. No major complication was noted in either group.
CONCLUSIONS: Intravesical onabotulinumtoxinA injection is a safe and effective treatment for DM patients with refractory DO. Patients with DM should be informed of the increased risk of large PVR before initiation of treatment.
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