Aim To evaluate the non‐inferiority of the transcutaneous electrical stimulation technique, as compared with the percutaneous therapy (PTNS), regarding the efficacy in symptoms and QoL improvement in patients with overactive bladder (iOAB). Methods Patients with overactive detrusor (DO) and persisting symptoms after first‐line or second‐line treatment were randomized to receive either transcutaneous therapy or PTNS 1 day a week (30 min at 20 Hz and 200 cycles/s) for 12 weeks. Data from a 3‐day voiding diary and a self‐reported QoL‐questionnaire were collected pre‐treatment and at week 12. Non‐inferiority was analyzed by estimating the mean change (95% confidence interval) of daytime micturition frequency. Statistical significance level was set at P < 0.05. Results Sixty‐eight patients were included (67.6% women), mean age 59.6 years (SD 16.1). According to ITT analysis, daytime frequency decreased in both groups without statistically significant differences between them at the end of the treatment (adjusted difference 0.8; 95%CI; −0.1; 1.7); nor were differences in symptoms improvement for the variables collected through the 3‐day voiding diary. Both techniques lessened urgency incontinence episodes by more than 50% and greatly improved the QoL. There were no relevant side effects and overall adherence to the treatment was 89.7%. Conclusions This is the first RCT that evaluates the efficacy of the transcutaneous technique compared to the PTNS, and demonstrates non‐inferiority in decreasing daytime frequency. Reduction in urgency incontinence episodes and improvement of QoL were also observed. These results and ease of application of transcutaneous neuromodulation may lead to a greater prescribing of this technique.

Aim: To compare the efficacy of transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS) regarding patientreported outcomes measures, specifically quality-of-life (QoL) improvement and patient's treatment benefit, on symptoms associated with overactive bladder (OAB). Methods: Patients with refractory OAB symptoms and detrusor overactivity were randomized to receive TTNS or PTNS for 12 weeks. Data from self-report OAB questionnaire short form (q-SF) and incontinence (I)-QoL questionnaires were collected pretreatment and at Weeks 6 and 12. Patients' self-perceived benefits on symptoms (treatment benefit scale, TBS) were also gathered. Mean change in scores within and between groups were estimated. Results: Sixty-eight adult patients (67.6% women) were included in the intention to treat analysis. Of those, 61 completed all questionnaires and were analyzed as per protocol. Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p < .001), being the differences much higher than the minimal important difference in both questionnaires. The scores of the OAB-q-SF scales (symptoms bother and health-related QoL) showed no statistically significant differences between the two groups. Similarly, the differences regarding the I-QoL questionnaire were statistically nonsignificant either (p = .607). When assessing the treatment benefit on symptoms, TBS responses between groups showed no statistical differences. Conclusion: A significant improvement of QoL was observed in both TTNS and PTNS groups. However, no patient-reported outcomes measures scores support a difference between the two groups. Therefore, these findings along

Background Radical prostatectomy is the gold standard treatment for men with localized prostate cancer. This technique is associated with post-operative urinary incontinence. Pelvic floor physiotherapy is a conservative, painless and economical treatment for this specific situation. Kegel exercises and perineal electrostimulation are common techniques to train pelvic floor muscles. The perineal electrostimulation can be applied to the patient with surface electrodes or by an intra-cavitary anal probe. This study proposes that transcutaneous perineal electrostimulation is as effective as intra-cavitary electrostimulation in reducing urinary incontinence secondary to radical prostatectomy. The main objective is to compare the efficacy of the treatment with transcutaneous perineal electrostimulation versus the same intra-cavitary treatment to reduce the magnitude of urinary incontinence after radical prostatectomy, and the impact on the quality of life. Methods This single-blind equivalence randomized controlled trial will include 70 man who suffer urinary incontinence post radical prostatectomy. Participants will be randomized into surface electrodes group and intra-anal probe group. The groups will receive treatment for 10 consecutive weeks. Outcomes include changes in the 24-h Pad Test, and ICIQ-SF, SF-12 and I-QoL questionnaires. Clinical data will be collected at baseline, 6 and 10 weeks after the first session, and 6 months after the end of treatment. Discussion The results will allow us to prescribe the most beneficial perineal electrostimulation technique in the treatment of urinary incontinence derived from radical prostatectomy. Trial registration ClinicalTrials.gov Identifier: NCT03587402. 27/06/2018

Aim To compare the efficacy of the treatment with transcutaneous perineal electrostimulation versus intracavitary electrostimulation to reduce the frequency of urinary incontinence after radical prostatectomy and the impact on the quality of life (QoL). Methods This single‐blind equivalence‐randomized controlled trial equally (1:1) randomly allocated men with urinary incontinence post radical prostatectomy into surface electrodes perineal group (intervention group, IG) and intra‐anal probe group (control group, CG). Outcomes included changes in the 24h‐Pad Test (main variable), and ICIQ‐SF (International Consultation on Incontinence Questionnaire Short‐Form), SF‐12 (Short Form Health Survey), and I‐QOL (incontinence quality of life questionnaire) questionnaires. Clinical data were collected at baseline, 6 and 10 weeks. For the comparisons between variables, χ2 test and Student's t test were used. Equivalence was analyzed by estimating the mean change (90% confidence interval) of urinary incontinence based on the Pad Test. The analysis was performed for the per‐protocol and the intention‐to‐treat populations. Statistical significance level was set at p < 0.05. Results Seventy patients were included, mean age 62.8 (SD 9.4) years. Mean baseline 24h‐Pad Test was 328.3 g (SD 426.1) and a significant decrease (p < 0.001) in the grams of urine loss at 5 weeks (159.1 g in the IG and 121.7 g in the CG), and at 10 weeks of treatment (248.5 g in the IG and 235.8 g in the CG) was observed. However, the final difference in the grams of urine loss between both treatments showed the absence of statistical significance (p = 0.874). In both groups, the ICIQ‐SF, I‐QOL, and SF‐12 questionnaires revealed a significant improvement in QoL. Conclusion Surface and intra‐anal electrostimulation treatments reduced significantly losses of urine, but differences in grams of urine loss throughout the therapy between groups were not significant, suggesting that the efficacy of the two treatments is not statistically different. Nonetheless, the improvement observed in both groups was statistically significant and clinically relevant.

Aim To evaluate the efficacy of adjuvant, capacitive resistive monopolar radiofrequency (CRMRF, INDIBA) treatment at 448 kHz together with physiotherapeutic techniques compared to a sham treatment with the same techniques, for pain reduction and quality of life (QoL) improvements in patients with chronic pelvic pain syndrome (CPPS). Methods A triple‐blind, randomized controlled trial (RCT) including patients with CPPS randomly allocated (1:1) to a CRMRF‐activated group (intervention) or a CRMRF‐deactivated one (control). Both groups received physiotherapeutic techniques and pain education weekly for 10 consecutive weeks. Data from a visual analogical scale and the SF‐12 questionnaire were collected at trial commencement and repeated at the 5th and 10th sessions. Pain intensity was considered the main outcome. For the comparisons between variables, the χ2 and Student's t test were used. Superiority was analyzed by estimating the mean change (95% confidence interval). Analysis was performed for the per‐protocol and the intention‐to‐treat populations. The statistical significance level was set at p < 0.05. Results Eighty‐one patients were included (67.9% women) with a mean age of 43.6 years (SD 12.9). CRMRF lessened pain scores by more than 2 points and improved QoL by 5 points. There were no relevant side effects and overall adherence to the treatment was 86.4%. Conclusions This is the first RCT that evaluates the efficacy of CRMRF (INDIBA) compared to a sham treatment, and demonstrates its superiority in decreasing pain and improving QoL. Such results may lead to greater prescribing of CRMRF when treating CPPS patients.