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The efficacy and safety of repetitive intravesical onabotulinumtoxin-A in the treatment of
interstitial cystitis/bladder pain syndrome: Long-term follow up
Eur Urol Suppl 2014;13;e463 Print!
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Lee C-L., Jiang Y-H., Jhang J-F., Kuo H-C.
Buddhist Tzu Chi General Hospital and Tzu Chi University, Dept. of Urology, Hualien, Taiwan
INTRODUCTION & OBJECTIVES: Currently, there is no cure for interstitial cystitis/ bladder pain syndrome (IC/BPS) and the treatment is
limited to symptomatic relief. Intravesical onabotulinumtoxin-A (BoNT-A) injection is a safe and effective therapeutic option, although its
long-term sustainability after single injection remains unsatisfactory. This study evaluated long-term efficacy and safety of repeated
intravesical BoNT-A injections.
MATERIAL & METHODS: From July 2006 to Aug 2012, consecutive patients with IC/BPS who failed conventional treatments were
prospectively enrolled. All subjects received an initial 100U of intravesical BoNT-A injection followed by repeated injections every 6 months
for up to 4 times or until he/she wished to discontinue. O’Leary-Sant symptom indexes (ICSI) and problem indexes (ICPI), visual analogue
score (VAS) for pain, urodynamic study (VUDS) parameters, 3-day voiding diary, global response assessment (GRA), adverse events were
recorded. All baseline values were compared at each treatment time point. Long-term successful results were analysed.
RESULTS:
Of these 104 patients, there were 45 subjects who had completed all 4 injections and available for follow-up. ICSI, ICPI, VAS, functional
bladder capacity (FBC) and GRA all showed significant improvement after repeated BoNT-A injections (Table 1). The occurrence of
adverse events did not increase with increasing number of BoNT-A injections (Table 2). Kaplan-Meier survival curves revealed better
success rate in those whom received repetitive injections (Fig.1).
Table 1. Changes of parameters in the 45 patients receiving all 4 repeated BoNT-A injections
N=45
BoNT-A 1 BoNT 2
BoNT 3
BoNT 4
ICSI
12.3±3.38
8.67±4.24
8.53±3.84 8.04±3.91 <0.0001
ICPI
11.5±2.91
7.89±4.38
7.62±4.29 6.31±4.59 <0.0001
OSS
23.7±85.9
16.6±8.22
16.2±7.92 14.3±8.31 <0.0001
VAS
5.36±2.24
3.67±2.28
3.33±2.43 2.78±2.34 <0.0001
FBC
135±74.6
169±82.3
204±96.1
Frequency 13.8±4.96
10.5±5.65
11.1±6.08 10.1±5.31 <0.0001
Noturia
3.84±1.99
3.09±1.69
3.02±2.29 3.16±2.59 0.072
Qmax
14.0±4.76
13.3±6.37
13.3±5.03 12.6±5.55 0.647
Volume
259±106
281.9±125 296±132
PVR
15.3±7.87
31.4±8.56
44.3±8.05 57.9±9.08 0.039
CBC
276±106
319±112
340±114
223±110
274±139
338±141
P value
<0.0001
0.297
0.012
MBC
686±206
739±209
742±206
758±199
0.030
GRA
0
1.39±1.04
1.65±0.82 1.87±1.15 <0.0001
Gr
1.73±1.03
1.64±0.93
1.32±0.92 1.24±0.96 0.010
Table 2. Adverse events reported at each treatment time point
None UTI Dysuria CISC AUR Hematuria Total
BoNT-A 1 62
6
34
2
104
BoNT-A 2 44
7
36
1
1
89
BoNT-A 3 30
10
22
1
1
64
BoNT-A 4 28
5
12
45
CONCLUSIONS: In this study, we have shown that repetitive intravesical injections of BoNT-A is safe, effective and sustainable in the
treatment of IC/BPS who were refractory to conventional treatment.