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

Not Applicable

Completed

Conditions: Stress Urinary Incontinence

Interventions: Other: sham EA
Other: EA

Registration Number: NCT02445573

Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham EA group	sham EA	-
EA group	EA	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Urine Leakage Measured by 1-hour Pad Test	Baseline and week 6

Secondary Outcome Measures

Name	Time	Method
Patient Self-evaluation of Therapeutic Effect	weeks 6, 18 and 30	Participants were asked to rate the extent of help that they received from treatment as no help, little help. moderate help or great help. Number of participants reporting different extent of help was collected.
Change From Baseline of the Total ICIQ-SF Scores	Baseline, and weeks 6, 18 and 30	The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.It was used to assess the influence of urinary incontinence on quality of life during the past 4 weeks retrospectively. It contained three items on frequency, amount of leakage, and overall impact on quality of life, and a fourth, non-scored item for the assessment of type of incontinence. A total score was summed by the scores of the first three items, ranging from 0 to 21. A higher value indicates increased severity.
Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)	Baseline, weeks 1-6, weeks 15-18 and weeks 27-30	Data of IEF was from 72-hour bladder diary recorded by participants over the last 72 hours of weeks 0 (baseline), weeks 2, 4, 6 (treatment period) and weeks 15-18,and 27-30 (follow-up period). The 72-hour IEF of weeks 1-6 equaled the sum of 72h IEF at weeks 2, 4 and 6 divided by 3; The 72-hour IEF of weeks 15-18 equaled the sum of 72h IEF at weeks 15-18 divided by 4; The 72-hour IEF of weeks 27-30 equaled the sum of 72h IEF at weeks 27-30 divided by 4.