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.
Background Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. This study aims to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 kHz as an adjunct treatment to other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS. Methods This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into a CRMRF activated group or a CRMRF deactivated group and receive physiotherapeutic techniques and pain education. The groups will undergo treatment for 10 consecutive weeks. At the beginning of the trial there will be an evaluation of pain intensity (using VAS), quality of life (using the SF-12), kinesiophobia (using the TSK-11), and catastrophism (using the PCS), as well as at the sixth and tenth sessions. Discussion The results of this study will show that CRMRF benefits the treatment of patients with CPPS, together with physiotherapeutic techniques and pain education. These results could offer an alternative conservative treatment option for these patients. Trial registration ClinicalTrials.gov NCT03797911. Registered on 8 January 2019.
Background Chronic Pelvic Pain Syndrome (CPPS) is a multifactorial disorder that affects 5.7–26.6% of women and 2.2–9.7% of men, characterized by a hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. The aim of this study is to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 KHz as an adjunct treatment to the other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS. Methods This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into CRMRF activated group or CRMRF deactivated group, together with physiotherapeutic techniques and pain education. The groups will receive treatment for 10 consecutive weeks. Pain intensity (with the VAS), quality of life (with the SF-12), kinesiophobia (with the TSK-11) and catastrophism (with the PCS) will be evaluated at the beginning, at the sixth and the tenth session. Discussion The results of this study will make it possible to prove that CRMRF benefits the treatment of patients with CPPS together with physiotherapeutic techniques and pain education. These results could offer another conservative treatment option for these patients. Trial registration: ClinicalTrials.gov Identifier: NCT03797911. Registered 8 January 2019, https://clinicaltrials.gov/ct2/show/NCT03797911
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