Clinical trial NCT02445573: Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI)
Official title: A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women With Pure Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
electroacupuncture
efficacy
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
timeFrame: Baseline and week 6
Secondary outcomes:
measure: Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)
timeFrame: Baseline, weeks 1-6, weeks 15-18 and weeks 27-30
measure: Change From Baseline of the Total ICIQ-SF Scores
timeFrame: Baseline, and weeks 6, 18 and 30
measure: Patient Self-evaluation of Therapeutic Effect
timeFrame: weeks 6, 18 and 30
Other outcomes:
measure: Adverse Events
timeFrame: weeks 1-30
Locations:
city: Beijing
country: China
facility: Guang'anmen hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu H, Liu B, Wu J, Du R, Liu X, Yu J, Liu Z. A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence. PLoS One. 2016 Mar 9;11(3):e0150821. doi: 10.1371/journal.pone.0150821. eCollection 2016.