PARIS, FRANCE (UroToday.com) - The etiology of bladder pain syndrome is unknown.
Therefore, the management of this condition is focused on pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A (BTX-A) has been shown to decrease noxious input. The results of recently published studies demonstrate the efficacy of BTX-A in the treatment of painful bladder symptoms. The aim of this study was to evaluate the efficacy and safety of BTX-A in patients suffering bladder pain syndrome with Hunner’s lesions.
The study was approved by the University ethics committee. Seventy-six female patients with bladder pain syndrome/interstitial cystitis (BPS/IC) were screened for the study. Hunner’s lesions were found in 51,3% (39/76) of cases. Seven patients from the group of 39 (17,9%) refused to participate in the study. After signing informed consent, 32 patients were randomized into an experimental (Group 1) and a control group (Group 2). The patients from Group 1 (15 patients) were given injections of 100 U of BTX-A diluted in 10 ml 0.9% NaCl. The injections were performed under spinal anesthesia using a cystoscope with a flexible needle in the trigone of the bladder only. The patients from the Group 2 received standard hydrodistention under spinal anaesthesia (17 patients). Primary end points: O’Leary–Sant symptom index and problem index scores were used for validation of subjective complaints from the BPS/IC patients. Patient pain intensity was scored using a 10-point visual analogue scale (VAS). Patient quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score system. Secondary safety end points: Uroflowmetry followed by postvoid urine volume measurement and kidney ultrasound were performed post-treatment.
The results of the study are presented below:
| Group 1 | Group 2 | ||||
| Clinical and urodynamic parameters | Baseline (mean ± SD) | 3 mo (mean ± SD) | Baseline (mean ± SD) | 3 mo (mean ± SD) | p level |
| O’Leary-Sant score for symptoms (0–20) | 14.5 ± 2.3[E11] | 9.4 ± 2.9 | 13.8 ± 3.7 | 8.8 ± 3.3 | >0.05 |
| O’Leary-Sant score for problems (0–16) | 12.4 ± 2.4 | 7.3 ± 2.1 | 11.9 ± 3.1 | 6.8 ± 2.5 | >0.05 |
| VAS score | 9.3 ± 0.9 | 5.8 ± 2.4 | 8.7 ± 1.2 | 6.1 ± 2.8 | >0.05 |
| Quality of life (0–6) | 5.1 ± 0.9 | 1.8 ± 0.4 | 6.3 ± 0.7 | 1.7 ± 0.6 | >0.05 |
| Postvoid residual volume (ml) | 13.1 ± 4.3 | 23.2± 3.3 | 12.3 ± 3.6 | 13± 2.6 | >0.05 |
| Qmax | 24.2 ± 4.6 | 14.6 ± 13.1 | 21.9 ± 3.8 | 26.9 ± 9.8 | >0.05 |
A trigonal injection of 100 U BTX-A results in similar efficacy compared to conventional bladder hydrodistention. There were no significant increases in the amount of residual urine, no decrease in uroflowmetry rate and no upper-urinary tract retention. Therefore, longer-term follow-up studies are warranted.
Presented by Zaitcev, AV, Kasyan, GR, Tsibulya, O, and Pushkar, DY at the 27th Annual European Association of Urology (EAU) Congress - February 24 - 28, 2012 - Le Palais des Congrès de Paris, Paris, France
Moscow State University of Medicine and Dentistry, Dept. of Urology, Moscow, Russia
View EAU 2012 Annual Meeting Coverage
