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.