Abstract | PURPOSE: MATERIALS AND METHODS: A multicenter, randomized, double-blind, placebo-controlled trial in patients with IC/BPS refractory to conventional treatment. Patients were randomized in a 2:1 ratio to hydrodistention plus suburothelial injections of BoNT-A 100 U ( Botox group) or the equivalent amount of normal saline (N/S group). The primary endpoint was a decrease in pain assessed using a visual analog scale (VAS) at week 8 after treatment. Secondary endpoints included voiding diary and urodynamic variables. The Wilcoxon sign rank and rank sum tests were used for statistical analyses. RESULTS: A total of 60 patients (8 males, 52 females, age 50.8 ± 13.9 years) including 40 in the Botox and 20 in the N/S groups were enrolled. At week 8, a significantly greater reduction of pain was observed in the Botox group compared to the N/S group (-2.6 ± 2.8 vs. -0.9 ± 2.2, P = 0.021). The other variables did not differ significantly between groups except for cystometric bladder capacity, which was increased significantly in the Botox group. The overall success rates were 63% (26/40) in the Botox group and 15% (3/20) in the N/S group (P = 0.028). Adverse events did not differ between the groups. CONCLUSION:
Intravesical injections of 100 U of BoNT-A effectively reduced bladder pain symptoms in patients with IC/BPS. The adverse events were acceptable. Neurourol. Urodynam. 35:609-614, 2016. © 2015 Wiley Periodicals, Inc.
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Authors | Hann-Chorng Kuo, Yuan-Hong Jiang, Yao-Chou Tsai, Yuh-Chen Kuo |
Journal | Neurourology and urodynamics
(Neurourol Urodyn)
Vol. 35
Issue 5
Pg. 609-14
(06 2016)
ISSN: 1520-6777 [Electronic] United States |
PMID | 25914337
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2015 Wiley Periodicals, Inc. |
Chemical References |
- Neuromuscular Agents
- Botulinum Toxins, Type A
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Topics |
- Administration, Intravesical
- Adult
- Aged
- Botulinum Toxins, Type A
(administration & dosage)
- Cystitis, Interstitial
(drug therapy)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Neuromuscular Agents
(administration & dosage)
- Pain Measurement
- Prospective Studies
- Treatment Outcome
- Young Adult
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