Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, electroacupuncture, efficacy
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.
Interventions
OTHEREA
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.
OTHERsham 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline of Urine Leakage Measured by 1-hour Pad Test | Baseline and week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | weeks 1-30 | Number of participants who experienced Adverse Events was collected. |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks. | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | EA Group | Total | Sham EA Group |
|---|---|---|---|
| 72-hour incontinence episode frequency (IEF) | 4.00 episodes | 5.00 episodes | 5.00 episodes |
| Age, Continuous | 59.05 years STANDARD_DEVIATION 7.91 | 58.60 years STANDARD_DEVIATION 8.07 | 57.97 years STANDARD_DEVIATION 8.42 |
| BMI | 23.44 kg/m^2 | 23.13 kg/m^2 | 22.70 kg/m^2 |
| Childbearing no | 0 participants | 2 participants | 2 participants |
| Childbearing yes | 40 participants | 78 participants | 38 participants |
| Duration of disease | 5.04 years | 5.00 years | 5.00 years |
| Educational level Preliminary education and below | 2 participants | 7 participants | 5 participants |
| Educational level Secondary education | 30 participants | 51 participants | 21 participants |
| Educational level Tertiary education | 8 participants | 22 participants | 14 participants |
| Ever received SUI treatment no | 34 participants | 72 participants | 38 participants |
| Ever received SUI treatment yes | 6 participants | 8 participants | 2 participants |
| Hysterectomy no | 37 participants | 75 participants | 38 participants |
| Hysterectomy yes | 3 participants | 5 participants | 2 participants |
| Initial childbearing age | 24.65 years STANDARD_DEVIATION 2.94 | 24.19 years STANDARD_DEVIATION 2.91 | 23.71 years STANDARD_DEVIATION 2.84 |
| International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score | 9.08 units on a scale STANDARD_DEVIATION 4.24 | 8.94 units on a scale STANDARD_DEVIATION 4.37 | 8.80 units on a scale STANDARD_DEVIATION 4.54 |
| Menopause no | 9 participants | 19 participants | 10 participants |
| Menopause yes | 31 participants | 61 participants | 30 participants |
| Number of births 0 | 0 participants | 2 participants | 2 participants |
| Number of births 1 | 25 participants | 50 participants | 25 participants |
| Number of births 2 | 9 participants | 16 participants | 7 participants |
| Number of births ≥3 | 6 participants | 12 participants | 6 participants |
| Number of cesarean no | 40 participants | 80 participants | 40 participants |
| Number of cesarean yes | 0 participants | 0 participants | 0 participants |
| Number of vaginal delivery | 1.00 vaginal delivery | 1.00 vaginal delivery | 1.00 vaginal delivery |
| Severity of SUI rated by amount of urine leakage measured by 1-hour pad test Mild (1.1-9.9 g) | 24 participants | 56 participants | 32 participants |
| Severity of SUI rated by amount of urine leakage measured by 1-hour pad test Moderate (10-49.9 g) | 16 participants | 22 participants | 6 participants |
| Severity of SUI rated by amount of urine leakage measured by 1-hour pad test Severe (≥50 g) | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urine leakage measured by 1-hour pad test | 5.30 g | 4.90 g | 4.60 g |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
Time frame: Baseline and week 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EA Group | Change From Baseline of Urine Leakage Measured by 1-hour Pad Test | 2.50 g |
| Sham EA Group | Change From Baseline of Urine Leakage Measured by 1-hour Pad Test | 0.05 g |
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.
Time frame: Baseline, weeks 1-6, weeks 15-18 and weeks 27-30
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 6 | 2.00 episodes |
| EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 18 | 3.00 episodes |
| EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 30 | 3.25 episodes |
| Sham EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 6 | 0.67 episodes |
| Sham EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 18 | 2.00 episodes |
| Sham EA Group | Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF) | week 30 | 1.00 episodes |
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.
Time frame: Baseline, and weeks 6, 18 and 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 6 | 2.68 units on a scale | Standard Error 3.19 |
| EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 18 | 5.60 units on a scale | Standard Error 4.19 |
| EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 30 | 5.89 units on a scale | Standard Error 4.29 |
| Sham EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 6 | 0.16 units on a scale | Standard Error 2.29 |
| Sham EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 18 | 2.13 units on a scale | Standard Error 4.2 |
| Sham EA Group | Change From Baseline of the Total ICIQ-SF Scores | week 30 | 1.48 units on a scale | Standard Error 3.39 |
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.
Time frame: weeks 6, 18 and 30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 18 | 5 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 30 | 8 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 6 | 7 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 18 | 25 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 6 | 11 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 18 | 1 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 6 | 22 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 6 | 0 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 30 | 1 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 18 | 9 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 30 | 27 participants |
| EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 30 | 4 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 30 | 9 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 18 | 15 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 18 | 8 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 18 | 5 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 18 | 12 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 30 | 17 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 30 | 11 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | little-week 6 | 14 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 6 | 4 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | no-week 6 | 15 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | moderate-week 30 | 3 participants |
| Sham EA Group | Patient Self-evaluation of Therapeutic Effect | great-week 6 | 7 participants |
Other Pre-specified
Adverse Events
Number of participants who experienced Adverse Events was collected.
Time frame: weeks 1-30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EA Group | Adverse Events | serious adverse events | 0 participants |
| EA Group | Adverse Events | EA related adverse events | 3 participants |
| Sham EA Group | Adverse Events | serious adverse events | 0 participants |
| Sham EA Group | Adverse Events | EA related adverse events | 2 participants |