Intravesical botulinum toxin injections in an office-based setting: patients' comfort and tolerability

Bianchi D1, Iacovelli V1, Gigliotti F1, Petta F1, Parisi I2, Faralli F1, Bove P1, Vespasiani G1, Finazzi Agrò E1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 730
Non Discussion Abstracts
Scientific Non Discussion Abstract Session 36
Detrusor Overactivity Overactive Bladder Urgency Urinary Incontinence Incontinence
1. Dept. Exp. Medicine and Surgery, Tor Vergata University, Rome, Italy, 2. Neuro-urology Unit, IRCCS S. Lucia, Rome, Italy
Links

Abstract

Hypothesis / aims of study
Intravesical administration of botulinum toxin A is a recognized treatment for detrusor overactivity in both neurogenic and non-neurogenic patients. The primary endpoint of the present preliminary study was to evaluate patients’ comfort and tolerability of intravesical botulinum toxin injection in an office-based setting in comparison to other minimally invasive procedures from other medical specialties. A secondary endpoint was to compare the same procedure performed in the operating room and in an office-based setting in patients who had previously undergone the procedure in the operating room.
Study design, materials and methods
We enrolled all the patients who had undergone intravesical botulinum toxin injection in an office-based setting under local anesthesia (bladder instillation of lidocaine 2%, 10 mL + sodium bicharbonate 10mEq/10mL, 10 mL, diluited with sodium chloride 0.9%, 40 mL) from May–December 2017, regardless of whether they had previously undergone the same procedure in the operating room. No standardized questionnaire was available, so we modified the questionnaire used by Rees et al. for dye laser treatment to the upper aerodigestive tract (see Table 1). The questionnaire scores ranged from 1–10, with 1 representing “the worst pain” and 10 “no pain:”
- Question 1: Overall (1 to 10)
- Question 2: Bladder (1 to 10)
- Question 3: Urethra: (1 to 10)
- Question 4: Please, rate your pain after the procedure (1 to 10)
- Question 5: Did you require any pain pills? (If YES, what type of pills?)
- Question 6) Have you had previous surgical treatment in the operating room for your condition?
- Question 7: How would you rate your inoffice pain recovery if compared to pain recovery after the treatment in the operating room? LESS PAIN - SAME PAIN – MORE PAIN
- Question 8: Given the following choices, what is your preference for treatment of your disease? OPERATING ROOM - EQUAL PREFERENCE – OFFICE SETTING
- Question 9: Why did you prefer the above treatment? TIME - COMFORT – OTHER (specify).
We contacted the patients by telephone, and the questionnaire was administered by a “blinded” investigator who was not previously involved in the procedure.
Results
Twenty patients were enrolled. We were unable to contact three of them, but the remaining 17 patients (11 males, 6 females) agreed participate in the study. Six of them had been previously diagnosed with idiopathic detrusor overactivity, while the other 11 patients had a neurogenic overactive bladder (2 multiple sclerosis; 2 encephalitis; 7 spinal cord injury). The mean age was 48.3 years (SD ±13.5 years, ranging 22–65 years). Overall, the general comfort score was >7, both during the procedure and over the post-operative days.
Eleven of the 17 patients had previously undergone the same procedure in the operating room. Overall, 9 of the 11 patients (81.8%) responded that they would prefer to repeat the procedure in an office-based setting rather than in the operating room. The results are summarized in Table 2.
Interpretation of results
Our study provides some insights into the use of intravesical onabotulinum-toxin A injections as an office-based regimen. It was a feasible procedure with a good patient comfort and tolerability. The majority of patients in our series declared they would choose to undergo the same procedure as an office-based regimen.
Concluding message
Despite several limitations, this study shows that intradetrusorial onabotulinum-toxin A injection is a feasible procedure for an office-based regimen, with a good patient comfort and tolerability. Given that onabotulinum-toxin A injection usually needs periodic repetitions, our take-home message is that office-based management will allow clinicians to arrange the treatment sessions more easily, with no impact on operating room activity. Moreover, from the patient’s point of view, we observed a better acceptance of the procedure, which mainly related to an easier session arrangement and to a higher degree of comfort than is obtainable in the operating room setting. Larger scale studies that include stratification between neurogenic and non-neurogenic populations are needed to confirm our preliminary results.

Table 1: Phone survey for intravesical botulinum toxin infiltration (adapted from Rees JR et al).

Table 2: Questionnaire results for intravesical botulinum toxin infiltration (see also Table 1).
Figure 1
Figure 2
References
  1. Giannantoni A, Proietti S, Costantini E, et al: OnabotulinumtoxinA intravesical treatment in patients affected by overactive bladder syndrome: best practice in real-life management. Urologia. 2015 Jul-Sep;82(3):179-83. doi: 10.5301/uro.5000120. Epub 2015 May 20
  2. Rees CJ, Halum SL, Wijewickrama RC, et al: Patient tolerance of in-office pulsed dye laser treatments to the upper aerodigestive tract. Otolaryngol Head Neck Surg. 2006 Jun;134(6):1023-7
  3. Giannantoni A, Carbone A, Carone R, et al: Real-life clinical practice of onabotulinum toxin A intravesical injections for overactive bladder wet: an Italian consensus statement. World J Urol. 2017 Feb;35(2):299-306. doi: 10.1007/s00345-016-1847-x. Epub 2016 May 26.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics not Req'd It was a telephonic interview Helsinki Yes Informed Consent Yes
24/04/2024 14:07:21