NCT02445573

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
OTHER	EA	When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
OTHER	sham EA	When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-05-15
• Last updated: 2015-06-15
• Results posted: 2015-06-15

Locations

1 site across 1 country: China