Botulinum toxin A as a treatment for urinary incontinence. Use of 5 vs 20 intravesical injections.

Fernández Mederos A1, Medina Castellano M1, Rodríguez Rodríguez R1, Ortega Cárdenes I1, Ponce Arocha D1, Ceccarelli C1, Pérez Morales E1, Carballo Rastrilla S1, García Hernández J1, Martín Martínez A1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 595
E-Poster 3
Scientific Open Discussion Session 31
Friday 6th September 2019
13:55 - 14:00 (ePoster Station 4)
Exhibition Hall
Overactive Bladder Female Urgency Urinary Incontinence
1.Servicio de Obstetricia y Ginecología. Hospital Universitario Materno-Infantil de Canarias, Las Palmas de Gran Canaria
Presenter
A

Alicia Martín Martínez

Links

Poster

Abstract

Hypothesis / aims of study
In those patients who do not respond to the first line of treatment in overactive bladder, that is, behavioral therapy, anti-muscarinic therapy has traditionally been used as the second line of treatment. However, their significant side effects can be the reason for non-adherence, even in cases of significant clinical success.  intra-detrusor injection of botulinum toxin may have beneficial effects in those patients with medication refractory detrusor overactivity and may offer a new minimally invasive alternative to patients with severe overactive bladder symptoms.
Our aim was to determine whether 100U toxin injected at 5 sites rather than 20 sites throughout the detrusor muscle show comparable results in the treatment of patients with overactive bladder and urgency urinary incontinence refractory to pharmacological therapy.
Study design, materials and methods
A retrospective observational study was conducted on two patient series in which the baseline characteristics were studied, 15 days after the administration of botulinum toxin, at 4 months (coinciding with the highest activity peak of the toxin) and finally, when the patient was discharged from the Pelvic Floor Unit.
A total of 58 patients were included. Thirty patients  received botulinum toxin with 20 injections and twenty-eight patients were treated with 5 injections. 
The study period was from January 14, 2016 to May 29, 2017 for the patients in which botulinum toxin was administered with 20 injections. Since that date, the procedure protocol was changed at the author's institution and the toxin A was administered through 5 injections, in a study time interval from August 26, 2017 to August 27, 2018.
Results
The two populations studied were absolutely comparable according to: age, body mass index, daytime and  night-time urinary frequency and number of disposable absorbent products (referred at the baseline visit). However, they were not comparable regarding the ICIQ-UI SF score (Questionnaire that evaluates the impact of urinary incontinence on the quality of life) result prior to the administration. The ICIQ-UI SF score was 9.31 in the 20 site injection group, compared to 12.32 in the  5 site injection group. This meant that the quality of life related with urinary incontinence in the group of the 5 injections was basally worse than the 20 injections group. 
No differences were found on personal history of diabetes mellitus, tobacco habit, consumption of bladder irritants, previous pharmacological treatment, percentage of patients with pure urgency urinary incontinence (versus mixed urinary incontinence), presence of pelvic organ prolapse and access to behavioral therapy.
However, on analysis, it was observed that 3 patients that pertained to the 5 injections site group had a history of chemotherapy and radiotherapy due to a gynecological cancer. In addition, 64.3% (18 cases) of patients with 5 injections had a previous intravesical administration.
Estrogen therapy was administered in a higher number of patients within the group of 5 injections, (57.1% vs 20%), given a greater sensitivity about this treatment at present in these patients, compared to the previous therapeutic protocol.
There were no differences regarding to the personal history of surgical intervention of urinary incontinence in both 2 groups.
In both groups, the most frequent was the use of pads as disposable absorbent products.
In all patients the procedure was well tolerated, both in the previous treatment group and the current one .
Behavioral therapy was taught by the Pelvic Floor Unit nursing team. In the 20 injections group involved to 90% of the patients, and in the 5 injections group, to 85.7%.
After 14 days from treatment with the botulinum toxin A, 42.9% of the 20 injections group did not need disposable absorbent products yet, with the most frequent use of pads (46.2%) in the group of 5 injections.
4 months after administration, a greater complete continence was statistically significant in the group of 20 injections (53.3% vs 17.9%), being partial continence the most frequent in the group of 5 injections (42.9% vs 33.3%).
There were no differences in the presence of urinary infection, and none needed for intermittent catheterization. There was a isolated case of hematuria in the group of 5 injectinos.
There was no difference in the need to raise the dose of botulinum toxin or even in the need of stopping any previous medication for urinary incontinence.
It is important to emphasize that during follow-up, 5 cases were lost in the group of 5 injections,  compared to just one loss in the group of 20 injections.
In the group of 20 injections the ICIQ-UI SF after 4 months was 2.93 versus 8.70 in the group of 5 injections, as at baseline, the 5 injections group were more affected by their symptoms.
Interpretation of results
This research show as an evidence that none of the patients to whom the botulinum toxin A was administered through 20 injections,  had been subjected to the same treatment previously. However, 64% of the patients in the group of 5 injections,  had been subjected to a previous administration of botulinum toxin A at 20 sites. 
Therefore,  the presence of greater symptomatology in the group of 5 injections was an observed and objectified fact.
Concluding message
Although more studies are needed to determine the safety and efficacy of 5 injections administration for botulinum toxin, our results support that this modification in the administration of the treatment can be not only as effective as a 20 injections distribution, but faster.
Disclosures
Funding NONE Clinical Trial No Subjects Human Ethics not Req'd Retrospective study. Collecting data from standardized clinical assistance.
28/03/2024 08:58:13