Trial Outcomes & Findings for Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI) (NCT NCT02445573)
NCT ID: NCT02445573
Last Updated: 2015-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline and week 6
Results posted on
2015-06-15
Participant Flow
Participants were recruited through posters and specialist's recommendations in Guang'anmen hospital of China Academy of Chinese Medical Sciences, Beijing, China, from December 2012 to June 2014.
A total of 181 women with UI were invited to participate in the study. 101 women were excluded from the trial before assignment to groups, of whom 87 did not meet inclusion criteria, 10 declined to participate, 4 were afraid of acupuncture. 80 women were eligible and randomly assigned to EA group (n=40) or sham EA group (n=40).
Participant milestones
| Measure |
EA Group
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 Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
EA Group
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 Group
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI)
Baseline characteristics by cohort
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.05 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
57.97 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
58.60 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Educational level
Preliminary education and below
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Educational level
Secondary education
|
30 participants
n=5 Participants
|
21 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Educational level
Tertiary education
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Childbearing
yes
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Childbearing
no
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of births
0
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of births
1
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Number of births
2
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Number of births
≥3
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Initial childbearing age
|
24.65 years
STANDARD_DEVIATION 2.94 • n=5 Participants
|
23.71 years
STANDARD_DEVIATION 2.84 • n=7 Participants
|
24.19 years
STANDARD_DEVIATION 2.91 • n=5 Participants
|
|
Number of vaginal delivery
|
1.00 vaginal delivery
n=5 Participants
|
1.00 vaginal delivery
n=7 Participants
|
1.00 vaginal delivery
n=5 Participants
|
|
Number of cesarean
yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of cesarean
no
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Menopause
yes
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Menopause
no
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Hysterectomy
yes
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Hysterectomy
no
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
BMI
|
23.44 kg/m^2
n=5 Participants
|
22.70 kg/m^2
n=7 Participants
|
23.13 kg/m^2
n=5 Participants
|
|
Duration of disease
|
5.04 years
n=5 Participants
|
5.00 years
n=7 Participants
|
5.00 years
n=5 Participants
|
|
Ever received SUI treatment
yes
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Ever received SUI treatment
no
|
34 participants
n=5 Participants
|
38 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Severity of SUI rated by amount of urine leakage measured by 1-hour pad test
Mild (1.1-9.9 g)
|
24 participants
n=5 Participants
|
32 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Severity of SUI rated by amount of urine leakage measured by 1-hour pad test
Moderate (10-49.9 g)
|
16 participants
n=5 Participants
|
6 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Severity of SUI rated by amount of urine leakage measured by 1-hour pad test
Severe (≥50 g)
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Urine leakage measured by 1-hour pad test
|
5.30 g
n=5 Participants
|
4.60 g
n=7 Participants
|
4.90 g
n=5 Participants
|
|
72-hour incontinence episode frequency (IEF)
|
4.00 episodes
n=5 Participants
|
5.00 episodes
n=7 Participants
|
5.00 episodes
n=5 Participants
|
|
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score
|
9.08 units on a scale
STANDARD_DEVIATION 4.24 • n=5 Participants
|
8.80 units on a scale
STANDARD_DEVIATION 4.54 • n=7 Participants
|
8.94 units on a scale
STANDARD_DEVIATION 4.37 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 6Outcome measures
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
|---|---|---|
|
Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
|
2.50 g
Interval 1.8 to 14.6
|
0.05 g
Interval -0.28 to 0.5
|
SECONDARY outcome
Timeframe: Baseline, weeks 1-6, weeks 15-18 and weeks 27-30Data 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.
Outcome measures
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
|---|---|---|
|
Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)
week 6
|
2.00 episodes
Interval 0.42 to 3.25
|
0.67 episodes
Interval -0.59 to 2.25
|
|
Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)
week 18
|
3.00 episodes
Interval 1.06 to 5.0
|
2.00 episodes
Interval 0.0 to 5.19
|
|
Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)
week 30
|
3.25 episodes
Interval 1.25 to 5.69
|
1.00 episodes
Interval -0.69 to 2.88
|
SECONDARY outcome
Timeframe: Baseline, and weeks 6, 18 and 30The 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.
Outcome measures
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
|---|---|---|
|
Change From Baseline of the Total ICIQ-SF Scores
week 6
|
2.68 units on a scale
Standard Error 3.19
|
0.16 units on a scale
Standard Error 2.29
|
|
Change From Baseline of the Total ICIQ-SF Scores
week 18
|
5.60 units on a scale
Standard Error 4.19
|
2.13 units on a scale
Standard Error 4.20
|
|
Change From Baseline of the Total ICIQ-SF Scores
week 30
|
5.89 units on a scale
Standard Error 4.29
|
1.48 units on a scale
Standard Error 3.39
|
SECONDARY outcome
Timeframe: weeks 6, 18 and 30Participants 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.
Outcome measures
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
|---|---|---|
|
Patient Self-evaluation of Therapeutic Effect
no-week 6
|
0 participants
|
15 participants
|
|
Patient Self-evaluation of Therapeutic Effect
little-week 6
|
7 participants
|
14 participants
|
|
Patient Self-evaluation of Therapeutic Effect
moderate-week 6
|
11 participants
|
4 participants
|
|
Patient Self-evaluation of Therapeutic Effect
great-week 6
|
22 participants
|
7 participants
|
|
Patient Self-evaluation of Therapeutic Effect
no-week 18
|
1 participants
|
15 participants
|
|
Patient Self-evaluation of Therapeutic Effect
little-week 18
|
5 participants
|
8 participants
|
|
Patient Self-evaluation of Therapeutic Effect
moderate-week 18
|
9 participants
|
5 participants
|
|
Patient Self-evaluation of Therapeutic Effect
great-week 18
|
25 participants
|
12 participants
|
|
Patient Self-evaluation of Therapeutic Effect
no-week 30
|
1 participants
|
17 participants
|
|
Patient Self-evaluation of Therapeutic Effect
little-week 30
|
4 participants
|
11 participants
|
|
Patient Self-evaluation of Therapeutic Effect
moderate-week 30
|
8 participants
|
3 participants
|
|
Patient Self-evaluation of Therapeutic Effect
great-week 30
|
27 participants
|
9 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: weeks 1-30Number of participants who experienced Adverse Events was collected.
Outcome measures
| Measure |
EA Group
n=40 Participants
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 Participants
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.
|
|---|---|---|
|
Adverse Events
serious adverse events
|
0 participants
|
0 participants
|
|
Adverse Events
EA related adverse events
|
3 participants
|
2 participants
|
Adverse Events
EA Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham EA Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EA Group
n=40 participants at risk
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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
|
Sham EA Group
n=40 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
hematoma
|
5.0%
2/40 • Number of events 2 • 30 weeks
|
0.00%
0/40 • 30 weeks
|
|
Injury, poisoning and procedural complications
persistent pain after EA
|
2.5%
1/40 • Number of events 1 • 30 weeks
|
2.5%
1/40 • Number of events 1 • 30 weeks
|
|
General disorders
fatigue
|
0.00%
0/40 • 30 weeks
|
2.5%
1/40 • Number of events 1 • 30 weeks
|
Additional Information
Dr. Huanfang Xu
Guang'anmen hospital of China Academy of Chinese Medical Sciences
Phone: +86 10 8800 1124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place