COMBINED BOTULINUM TOXIN THERAPY AND PERCUTANEOUS TIBIAL NERVE STIMULATION IN THE REHABILITATION OF WOMEN WITH URGENCY URINARY INCONTINENCE ASSOCIATED WITH DIABETES MELLITUS.

OBJECTIVE: To evaluate the clinical efficacy and safety of a combined rehabilitation program consisting of intradetrusor injection of botulinum toxin type A followed by a course of percutaneous tibial nerve stimulation (PTNS) in women with urgency urinary incontinence associated with diabetes mellitus. MATERIALS AND METHODS: This prospective, non-randomized comparative clinical study included 135 women with type 2 diabetes mellitus. Of these, 105 women had urgency urinary incontinence persisting despite standard conservative therapy and entered the treatment comparison, and 30 women with diabetes mellitus but without urgency urinary incontinence or overactive bladder symptoms served as a non-incontinent reference (control) group. Assignment of the 105 symptomatic women to treatment was made prospectively on the basis of predefined clinical eligibility for third-line therapy and documented patient preference; no randomization procedure was used. The main group (n=50) received intradetrusor injection of botulinum toxin type A with hemagglutinin complex at a total dose of 300 U followed by 12 weekly PTNS sessions. The comparison group (n=55) received standard conservative therapy. The reference group received no study intervention and was used only for general clinical and nosological characterization; it was not included in any efficacy or safety comparison. The primary endpoint was the change in the number of daily urgency urinary incontinence episodes after 12 weeks. RESULTS: After 12 weeks, the frequency of urgency urinary incontinence episodes decreased from 5.8±1.4 to 1.4±0.8 episodes per day in the main group and from 5.7±1.3 to 3.9±1.2 episodes per day in the comparison group. The between-group difference in final values was -2.5 episodes per day (95% CI: -2.9 to -2.1; p<0.001). The main group also demonstrated a more pronounced decrease in ICIQ-SF score, OAB-q Symptom Bother score and NGF/Cr level, an increase in effective voided volume, and improvement in pelvic floor ENMG parameters. Transient urinary retention was recorded in 3 patients (6.0%) in the main group and was reversible. CONCLUSION: A combined program including intravesical botulinum toxin therapy and PTNS provides a statistically and clinically significant reduction in symptoms of urgency urinary incontinence in women with diabetes mellitus and has an acceptable safety profile. Dynamic monitoring of postvoid residual urine is necessary to reduce the risk of complications after botulinum toxin therapy. Because treatment was not allocated at random, these findings should be regarded as hypothesis-generating and require confirmation in randomized controlled trials.