Application of methylene blue as an improvement of the injection technique of botulinum toxin A in the treatment of refractory idiopathic overactive bladder: prospective, single-blind (patient-blind), randomized trial.

INTRODUCTION: Refractory idiopathic overactive bladder (RIOAB) is a common condition with a significant negative impact on quality of life. Intravesical injection of botulinum toxin A (BTX-A) is widely used as an intervention for these cases. In the standard method the drug solution is colorless. The addition of dye such as methylene blue (MB) facilitates visualization during the procedure and may have a beneficial effect. AIM: To evaluate the injection of BTX-A with the addition of methylene blue (MB) against a standard method in the treatment of RIOAB. MATERIAL AND METHODS: In this 1-center, single-blinded, randomized controlled trial, we recruited 80 patients with RIOAB. A total of 39 were assigned to injection into the bladder wall of 100 U BTX-A with MB (in 9.5 ml normal saline + 0.5 ml MB), and 41 were assigned to BTX-A 100 U alone (in 10 ml normal saline). Cystoscopy with a submucosal injection of the solution was performed systematically, including the bladder triangle. Participants were assessed 6 and 12 weeks after the treatment using a Likert scale and OABSS questionnaire. RESULTS: Significant improvement was similar (result of 1 or 2 on the Likert scale) and was achieved in 66.7% and 69.2% after 6 weeks and in 63.9% and 64.1% after 12 weeks in the BTX-A + MB group and only-BTX-A group, respectively. There was a significant difference between the two groups (p = 0.049) in the total number of patients with complications: 2 (5.6%) vs. 9 (23.1%). CONCLUSIONS: The addition of MB to BTX for treatment of RIOAB patients does not influence treatment efficacy, while it limits the risk of complications.

[Practical aspects of the use of botulinum toxin in the treatment of idiopathic overactive bladder].

Idiopathic overactive bladder due to its high impact on quality of life and high prevalence is a significant problem in everyday clinical practice. Currently, we do not have medicines that allow patients to be cured completely. Therapy is focused on the elimination or reduction of symptoms. An established position in the treatment of this disease for many years has a botulinum toxin. This therapy is used in patients whose conservative methods have not improved or are not acceptable because of side effects. The therapeutic effect after the injection of bladder detrusor muscle is limited in time and does not occur in all patients. Patients who benefit from this therapy require repeated procedures to reduce the symptoms of the disease. Many authors modify the standard treatment protocol of botulinum toxin in idiopathic overactive bladder in search of better results. The main goal is to improve the efficiency and extend the duration of the drug while reducing side effects. Undoubtedly, the technique of botulinum toxin injection has an effect on the final effect of treatment. The location and depth of punctures, the dose of the drug, preparation of the drug solution, periprocedural management and prophylaxis, and observation of the patient after the procedure are some issues whose modifications in the literature have been studied in order to achieve additional benefits from this therapy. In our work, we discuss the technical and practical aspects of this procedure in the search for the most optimal treatment protocol with the use of botulinum toxin in the treatment of idiopathic overactive bladder.

Overactive bladder treatment: application of methylene blue to improve the injection technique of onabotulinum toxin A.

OBJECTIVE: The aim of this study was to test the addition of methylene blue (MB) to onabotulinum toxin A (BTX-A) solution in overactive bladder (OAB) treatment, as a means of facilitating observation of the injection site and assessing the distribution of the drug under the bladder mucosa during injection. Pharmacological interactions between BTX-A and MB were also evaluated. MATERIALS AND METHODS: The study was conducted between December 2014 and April 2016 on 30 patients: six males and 24 females (median age 57.7, range 23-80 years) diagnosed with OAB, who qualified for intravesical BTX-A injection. Each received 100 IU of BTX-A (Botox®; Allergan), dissolved in 9.5 ml of 0.9% NaCl with the addition of 0.5 ml of MB. Cystoscopy with submucosal injection of the solution was performed systematically, including the bladder triangle. For pharmacological evaluation, quantitative determination of MB was performed on a capillary electrophoresis system with diode array detection. RESULTS: In the course of 600 injections, the addition of MB facilitated the observation of the procedure; the exact distribution of the solution could not be observed in only 43 injections in seven patients. The range of distribution of the drug varied from 1 to 2.5 cm. Pharmacological evaluation based on visual observations and experiments showed that pharmaceutical interactions do not occur between MB and this commercially available formulation of BTX-A. CONCLUSIONS: Applying a coloured solution of BTX-A significantly facilitates observation of the procedure and assessment of drug distribution. There are no pharmaceutical interactions between MB and BTX-A.