Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: A randomized controlled trial.

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.

Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: Randomized controlled trial.

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.

Development and validation of a short version of the Female Sexual Function Index in the Spanish population.

BACKGROUND: The Female Sexual Function Index (FSFI) is a commonly used scale for the assessment of female sexual function. Our aim was to develop and validate a Spanish short version of the FSFI. METHODS: A parallel exploratory, sequential mixed-methods approach was used, involving 2 sites. The process consisted of 2 steps: (1) cognitive and content validation of the previously translated FSFI in the Spanish population, both through a focus group; and item selection based on the difficulty and discrimination parameters using item response theory (IRT), thereby obtaining a short version of the scale (sFSFI-sv); (2) assessment of test-retest reliability (intraclass correlation coefficient, ICC) of the sFSFI-sv. The presence or absence of a sexual disorder variable based on clinical interview was used on the Receiver Operating Characteristic (ROC) to establish the cut off point whose Area Under the Curve (AUC) based on sensibility and specificity was maximum. RESULTS: Specific modifications of the FSFI were made according to the focus group results. 114 women were included for IRT analysis. The initial IRT model pointed to the exclusion of items 1, 2, 5, 11, 18, and 19 (S-χ2 p < 0.001). Items 3, 9, 11, and 14 showed the best discrimination and difficulty parameters. On the basis of the IRT and focus group results, items 1, 3, 9, 12, 16, and 17 were included in the final sFSFI-sv. sFSFI-sv showed good reliability (ICC 0.91) in a group of 93 women. A total score ≤ 18 could indicate a higher risk of sexual disorder (sensitivity: 81.0%, specificity: 73.3%). CONCLUSION: A focus group and the IRT analysis allowed the development of a 6-item Spanish version of the FSFI, which showed good reliability in a group of Spanish women.

Patient-reported outcomes in the setting of a randomized control trial on the efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome.

AIM: To compare the efficacy of transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS) regarding patient-reported 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 with TTNS ease of application and less invasiveness may lead to an increased indication of this technique for OAB.

Interventions across the Retirement Transition for Improving Well-Being: A Scoping Review.

(1) Background: The work-to-retirement transition involves a process of psychologically and behaviorally distancing oneself from the workforce that is often accompanied by other social changes, which can influence health and well-being. However, research on interventions targeting the work-to-retirement transition to improve health status is limited. Our objective was to summarize and describe interventions aiming to improve well-being across the retirement transition; (2) Methods: We conducted a scoping review following the methodological framework described by Arksey and O'Malley; the Joanna Briggs Institute guidelines as well as the PRISMA-ScR statements; we systematically searched articles and gray literature to identify interventions and policies that aimed to improve well-being across the retirement transition. (3) Results: 15 publications were included, which comprised both experimental designs (n = 10) and systematic reviews (n = 5). (4) Conclusions: More research on how to promote overall well-being during the work-to-retirement transition is needed. The results of this scoping review show that most reported interventions address one single lifestyle behavior, and that relevant social determinants of health have been barely considered in their design. Future investigations need to consider vulnerable groups and country-specific structural conditions. Adopting a patient and public involvement approach will contribute to developing interventions that address the significant needs of those in the transition to retirement.

Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial.

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.