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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Other: sham EA

Other: EA

Study type

Interventional

Funder types

Other

Identifiers

NCT02445573

2012BAI24B01-021

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible women were 40 to 75 years of age, and met the clinical diagnosis recommendations of SUI by the International Consultation on Urological Diseases:
- involuntary urine leakage on effort, exertion, sneezing or coughing which stopped when the stress ends;
- visible involuntary leakage from the urethra synchronous with increased abdominal pressure, or a pad weight gain >1 g in 1-hour pad test;
- without symptoms of urinary frequency and urgency.

Exclusion criteria

Women were excluded from the study if they met any of the following criteria: *other type of urinary incontinence (UI) (urge, mixed, or overflow UI, etc);
- symptomatic urinary tract infection;
- ever received UI or pelvic surgery;
- a severity of pelvic organ prolapse ≥ degree 2;
- residual urinary volume >30 ml;
- maximum flow rate ≤ 20 ml/s;
- limited in walking, stairs climbing and running;
- receiving specialized treatment for SUI, or taking medicine affecting bladder function;
- serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis;
- being pregnant or breastfeeding;
- with cardiac pacemaker, metal allergy or severe needle phobia;
- unlike to give written formed consent.