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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445573
• Other study ID #: 2012BAI24B01-021
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: May 29, 2015
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guang'anmen hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Number of participants who experienced Adverse Events was collected.	weeks 1-30	Yes
Primary	Change From Baseline of Urine Leakage Measured by 1-hour Pad Test		Baseline and week 6	No
Secondary	Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)	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.	Baseline, weeks 1-6, weeks 15-18 and weeks 27-30	No
Secondary	Change From Baseline of the Total ICIQ-SF Scores	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.	Baseline, and weeks 6, 18 and 30	No
Secondary	Patient Self-evaluation of Therapeutic Effect	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.	weeks 6, 18 and 30	No