تعیین تاثیر PTNS و TTNS بر مثانه بیش فعال و سیستیت بینابینی/سندرم مثانه دردناک: یک مطالعه مروری نظام مند و متاانالیز

مجریان: هانیه صالحی پورمهر

خلاصه روش اجرا: This systematic review and meta-analysis is conducted based on the Cochrane Collaboration Handbook and PRISMA Statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) (18). Inclusion and Exclusion Criteria The PICO formation comprising the inclusion criteria are as follows: -Population: patients suffering from OAB, or PBS; -Intervention: PTNS, and/or TTNS; -Control: placebo (sham) treatment, or other actual treatment methods used for treating OAB and PBS; -Outcomes: Primary outcomes: Efficacy of treatment based on Daily voiding frequency, Mean voiding volume, post void residual volume (PRV), Maximum cystometric capacity (MCC), Daily leakage episodes (Incontinence), Urgency episodes, Nighttime voiding frequency, and Urge incontinence. Secondary outcomes were safety of these modalities. Exclusion criteria for the studies were being in languages other than English, study types other than quasi-experimental, randomized-controlled trials, or cohort as well as unavailability of the full text version for the article. We excluded all related neurogenic OAB studies, and the experiments that used TENS or SANS as an active intervention for management OAB. Study selection Following the search, all identified citations were collated and uploaded into EndNote, and duplicate studies were removed. Titles and abstracts were screened by two independent reviewers for assessment against the inclusion criteria for the review. The full texts of selected citations were assessed in detail against the inclusion criteria by two independent reviewers. Reasons for excluding full-text studies that do not meet the eligibility criteria were recorded and reported in the systematic review. Any disagreements that arise between the reviewers at each stage of the study selection process were resolved through discussion or with a third reviewer. The search results were reported in full in the final systematic review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram (19). Data extraction and quality assessment Two authors, each selected and extracted half of the studies found in the search results, independently. Extracted data from each study, provided available, include first author name, study publication year, study design, type of condition (OAB/PBS), type of intervention (PTNS/TTNS), control group medication, sample size, male percentage, mean age, BMI score, mean duration of symptoms, duration of intervention, medication dosage, any of the outcomes mentioned above, and ending stats of the sample. The retrieved articles were screened by two independent reviewers and then were critically appraised by Cochrane handbook for randomized controlled trials (RCTs), and Joanna Briggs Institute (JBI) checklist for quasi-experimental studies (https://jbi.global/critical-appraisal-tools). Data synthesis We made a meta-analysis based on the results of included studies which compared monotherapy with PTNS or TTNS with sham, placebo, no treatment or conservative management. We hadn’t analysis on the studies with other active pharmacotherapy or surgical method in control arm and the results of such studies are reported in supplementary file 1. Results for PBS were not subjected to the statistical analysis due to the lack of sufficient data. Meta-analysis of the data was done by using Review Manager 5.4 statistical software. Intention-to-treat analysis results and if not reported, the results of the per-protocol analysis were used for meta-analysis. All variables were continuous data. Mean ± SD was used to calculate the standardized mean difference and 95% confidence interval (CI). Statistical heterogeneity was analyzed using the I2 value and the result of the chi-square test. A P<0.05 for Cochran’s Q and I2>50% were considered suggestive of statistical heterogeneity. We used the fixed model for low heterogeneity and mixed model for high heterogeneity in parameter analysis. Forest plot was used to show results of meta-analysis if there were at least two POOL articles for that outcome. Results of the comprehensive meta-analysis to examine any potential publication bias in the studies are shown as Funnel plots. Methodological quality In the current study, JBI quality checklist was used to assess the internal and external validity of the selected quasi-RCTs studies, and two authors separately performed an assessment based on Cochrane handbook for RCTs. All articles had been issued in peer-reviewed journals. The evaluated domains were random sequence generation, allocation concealment, blinding, incomplete data on outcomes, selective reporting, and other bias