Hypothesis / aims of study
Electrical stimulation with pelvic floor muscle training is a well-established treatment option for earlier restoration of continence in patients after Radical Prostatectomy surgery (1). Electrical Stimulation (ES) is an effective treatment for patients with urinary incontinence (IU) especially those patients who are initially unable to identify and contract correctly the pelvic floor muscles (2, 3). However, there is a lack of controlled studies to evaluate the effects of ES only on the early recovery of urinary continence and quality of life (QoL) of those patients.
Study design, materials and methods
A prospective, blind, randomized, sham-controlled study to evaluate the effect of ES as an early treatment of UI after nerve sparing radical prostatectomy (RP) surgery, and its impact in patients’ QoL. Due to the lack of published studies with this intervention, we had a pilot sample (10 patients in each group). Based on the results of the pilot sample, we adopted for the calculation the percentage of 50.0% in the ES group and 10.0% in the control group. This same sample size allowed detecting a significance level of 5% with a power of 90.1%. The study included incontinent men after undergoing RP with bilateral preservation of the neurovascular bundle, total PSA <10ng/mL and Gleason score ≤ 7. The patients were divided into two groups: ES group (n=23) and control group (n=23). Initial evaluation included incontinence severity index through 1 hour Pad test and impact of QoL with International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). After removal of the urethral catheter UI treatment was performed for 6 months with self-adhesive electrodes were positioned in the tendinous center of the perineum and on dorsal surface of the base of the penis, twice a week, during 30 minutes and no contraction of pelvic floor muscles was required. For the control group, the device was turned on and parameters were adjusted, but there was no release of electrical current stimulus. Patients in both groups were informed that they might not feel stimuli in the penile region during rehabilitation. Patients were evaluated at 1, 3, 6, 9 and 12 months after the start of the procedures. The criteria for of 1.4g or lower and ICIQ-SF total score lower than before the treatment.
Results
The study included 46 men average of 60,2 years old. There were no differences in the patients’ demographic and clinical characteristics by treatment group. After 6 months of treatment, 81,8% of the patients of ES group, and 80% of control group were continents; 12 months after finishing the treatment, 95,5% and 94,7% of ES and control group were continents respectively; however there were no difference between the groups (p=1,000) (Table 1). After 3 months the ICIQ-SF score decreased significantly until month 9 in both groups (p<0.001), nevertheless the score was similar between the groups after finishing the treatment (p=0.895) (Table 2).
Interpretation of results
In our study both groups were continents and improved the QoL after finishing the treatment. Pelvic floor muscles training has been the first line of choice for men with IU after radical prostatectomy surgery, however we could not confirm the effectiveness of ES only as technique on the early recovery of urinary continence and QoL. ES seems requires the pelvic floor muscles contractions in order to be more effective.