N/A N=80 Randomized Double-blind Treatment

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

Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT02445573 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Change From Baseline of Urine Leakage Measured by 1-hour Pad Test — 2.50; 0.05 g

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EA (Other); sham EA (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Urine Leakage Measured by 1-hour Pad Test	2.50; 0.05	—
SECONDARY Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)	2.00; 0.67; 3.00; 2.00; 3.25; 1.00	—
SECONDARY Change From Baseline of the Total ICIQ-SF Scores	2.68; 0.16; 5.60; 2.13; 5.89; 1.48	—
SECONDARY Patient Self-evaluation of Therapeutic Effect	0; 15; 7; 14; 11; 4	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02445573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.