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Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI)

Stress Urinary Incontinence Clinical Trial

Official title:
A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women With Pure Stress Urinary Incontinence

Clinical Trial Summary

The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA) for women with pure stress urinary incontinence (SUI).

Clinical Trial Description

This was a pilot randomized, placebo controlled trial to preliminarily assess the efficacy of EA for women with pure SUI. Eligible participants were randomly assigned to EA group or sham EA group in a 1:1 ratio via a central randomization system by acupuncturists. Participants, outcome assessors and statisticians were blinded to treatment allocation. Subject blinding is achieved via the aid of adhesive pads used in both groups, placebo needle with a blunt tip and sham EA electrode lines. Assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. The investigators expanded the sample size to 80 cases (40 cases per group) to increase the reliability of the study. The investigators performed statistical analysis based on the intention-to-treat principle. All patients accepting randomization were included in the analysis. Missing data were filled in by the last observed value. Student t tests or Mann-Whitney U tests were used for the comparison of continuous variables; chi-square tests, Fisher's exact tests or Kruskal-Wallis H tests were used to compare categorical variables, as appropriate. For measures collected at two time points, paired t-tests or Wilcoxon signed rank tests were used as appropriate. A statistically significant difference was set at P<0.05. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02445573
Study type Interventional
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact
Status Completed
Phase N/A
Start date December 2012
Completion date July 2014
View Details
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