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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EA
sham EA
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, electroacupuncture, efficacy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Guang'anmen hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EA group

Sham EA group

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline of Urine Leakage Measured by 1-hour Pad Test

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 13, 2015
Last Updated
May 29, 2015
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02445573
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, electroacupuncture, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA group
Arm Type
Active Comparator
Arm Title
Sham EA group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
EA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham EA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
Time Frame
Baseline and week 6
Secondary Outcome Measure Information:
Title
Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)
Description
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.
Time Frame
Baseline, weeks 1-6, weeks 15-18 and weeks 27-30
Title
Change From Baseline of the Total ICIQ-SF Scores
Description
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.
Time Frame
Baseline, and weeks 6, 18 and 30
Title
Patient Self-evaluation of Therapeutic Effect
Description
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.
Time Frame
weeks 6, 18 and 30
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Number of participants who experienced Adverse Events was collected.
Time Frame
weeks 1-30

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, doctor
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26960195
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.
Results Reference
derived

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

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