Trial Outcomes & Findings for Acupuncture for Urinary Incontinence (NCT NCT00297427)
NCT ID: NCT00297427
Last Updated: 2016-10-24
Results Overview
Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.
COMPLETED
PHASE2
127 participants
Baseline to 1 Week post-intervention
2016-10-24
Participant Flow
Participant milestones
| Measure |
Acupuncture
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Phase 1: Initial Intervention
STARTED
|
64
|
63
|
|
Phase 1: Initial Intervention
COMPLETED
|
56
|
54
|
|
Phase 1: Initial Intervention
NOT COMPLETED
|
8
|
9
|
|
Phase 2: Optional Crossover for Sham
STARTED
|
54
|
0
|
|
Phase 2: Optional Crossover for Sham
Crossed Over to True Acupuncture
|
42
|
0
|
|
Phase 2: Optional Crossover for Sham
COMPLETED
|
38
|
0
|
|
Phase 2: Optional Crossover for Sham
NOT COMPLETED
|
16
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
STARTED
|
94
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
COMPLETED
|
60
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
NOT COMPLETED
|
34
|
0
|
Reasons for withdrawal
| Measure |
Acupuncture
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Phase 1: Initial Intervention
Withdrawal by Subject
|
8
|
5
|
|
Phase 1: Initial Intervention
Lost to Follow-up
|
0
|
3
|
|
Phase 1: Initial Intervention
Death
|
0
|
1
|
|
Phase 2: Optional Crossover for Sham
Withdrawal by Subject
|
15
|
0
|
|
Phase 2: Optional Crossover for Sham
Lost to Follow-up
|
1
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
Withdrawal by Subject
|
29
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
Lost to Follow-up
|
3
|
0
|
|
Phase 3: Follow-up Post-True Acupuncture
Could not complete outcome diary
|
2
|
0
|
Baseline Characteristics
Acupuncture for Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.31 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
57.41 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
56.86 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
|
29.47 Kg/m^2
STANDARD_DEVIATION 6.68 • n=5 Participants
|
29.54 Kg/m^2
STANDARD_DEVIATION 6.65 • n=7 Participants
|
29.50 Kg/m^2
STANDARD_DEVIATION 6.64 • n=5 Participants
|
|
Co-morbidities
|
2.92 co-morbid health problems
STANDARD_DEVIATION 2.37 • n=5 Participants
|
2.82 co-morbid health problems
STANDARD_DEVIATION 2.09 • n=7 Participants
|
2.87 co-morbid health problems
STANDARD_DEVIATION 2.23 • n=5 Participants
|
|
Number of prescription medications
|
2.20 Prescription medications
STANDARD_DEVIATION 2.2 • n=5 Participants
|
2.22 Prescription medications
STANDARD_DEVIATION 2.33 • n=7 Participants
|
2.21 Prescription medications
STANDARD_DEVIATION 2.26 • n=5 Participants
|
|
Vaginal deliveries
|
1.59 Vaginal deliveries
STANDARD_DEVIATION 1.51 • n=5 Participants
|
1.43 Vaginal deliveries
STANDARD_DEVIATION 1.24 • n=7 Participants
|
1.51 Vaginal deliveries
STANDARD_DEVIATION 1.38 • n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Hormone replacement therapy
Yes
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Hormone replacement therapy
No
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Hormone replacement therapy
No applicable (premenopausal)
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Limited mobility
Yes
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Limited mobility
No
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Incontinent episodes/day
|
2.19 episodes/day
STANDARD_DEVIATION 1.57 • n=5 Participants
|
2.59 episodes/day
STANDARD_DEVIATION 2.12 • n=7 Participants
|
2.39 episodes/day
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Duration of urinary incontinence
|
9.81 Years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
8.61 Years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
9.22 Years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Mental Health-Related Quality of Life
|
55.49 units on a scale
n=5 Participants
|
55.90 units on a scale
n=7 Participants
|
55.67 units on a scale
n=5 Participants
|
|
Physical Health-Related Quality of Life
|
54.32 units on a scale
n=5 Participants
|
53.83 units on a scale
n=7 Participants
|
54.17 units on a scale
n=5 Participants
|
|
Incontinence-Specific Quality of Life
|
55.95 units on a scale
n=5 Participants
|
61.43 units on a scale
n=7 Participants
|
57.78 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 Week post-interventionPopulation: Intention-to-treat
Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Percent Change in Incontinent Episodes
|
-38.26 percent change in incontinent episodes
Standard Deviation 42.63
|
-15.29 percent change in incontinent episodes
Standard Deviation 65.41
|
PRIMARY outcome
Timeframe: 4 weeks post true or sham acupuncturePopulation: Intention-to-treat analysis
Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Percent Change in Incontinent Episodes
|
-42.49 percent change in incontinent episodes
Standard Deviation 40.24
|
-34.47 percent change in incontinent episodes
Standard Deviation 49.98
|
PRIMARY outcome
Timeframe: 1 Week post-interventionPopulation: Intention-to-treat
Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Physical Health-Related Quality of Live
|
0 percentage change relative to baseline
Interval -3.78 to 7.29
|
0 percentage change relative to baseline
Interval -6.7 to 3.35
|
PRIMARY outcome
Timeframe: 4-weeks post-interventionPopulation: Intention-to-treat
Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Physical Health-Related Quality of Life
|
0.37 percentage change relative to baseline
Interval -2.12 to 10.73
|
0 percentage change relative to baseline
Interval -4.42 to 4.43
|
PRIMARY outcome
Timeframe: 1 week post-interventionPopulation: Intention to treat analysis
Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Mental Health Related Quality of Life
|
0 percentage change relative to baseline
Interval -5.71 to 7.29
|
2.66 percentage change relative to baseline
Interval 0.0 to 8.76
|
PRIMARY outcome
Timeframe: 4 weeks post true or sham acupuncturePopulation: Intention-to-treat
Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Mental Health Related Quality of Life
|
0 percentage change relative to baseline
Interval -5.59 to 3.58
|
1.81 percentage change relative to baseline
Interval -0.18 to 5.17
|
PRIMARY outcome
Timeframe: 1 Week post-interventionPopulation: Intention-to-treat analysis
Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Incontinence-Specific Quality of Life
|
26.02 percentage change relative to baseline
Interval 0.84 to 69.03
|
17.36 percentage change relative to baseline
Interval 0.53 to 48.61
|
PRIMARY outcome
Timeframe: 4-weeks post-interventionPopulation: Intention-to-treat
Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.
Outcome measures
| Measure |
Acupuncture
n=64 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Incontinence-Specific Quality of Life
|
48.01 percentage change relative to baseline
Interval -6.49 to 83.4
|
32.04 percentage change relative to baseline
Interval -16.84 to 65.49
|
PRIMARY outcome
Timeframe: monthly during follow-up up to 6 monthsPopulation: Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture
Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)
Outcome measures
| Measure |
Acupuncture
n=60 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Duration of Any Beneficial Effects
|
2.17 Months
Standard Error 0.25
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 4 weeks post-interventionPopulation: Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.
Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.
Outcome measures
| Measure |
Acupuncture
n=23 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=19 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Change in Bladder Capacity
|
60.45 milliliters
Standard Deviation 114.91
|
-17.89 milliliters
Standard Deviation 121.68
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post-treatmentDocumentation of a diagnostic impression of stress urinary incontinence following urodynamics
Outcome measures
| Measure |
Acupuncture
n=23 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=19 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Urodynamic Diagnostic Impression of Stress Urinary Incontinence
Baseline
|
16 participants
|
6 participants
|
|
Urodynamic Diagnostic Impression of Stress Urinary Incontinence
4 weeks post-intervention
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post true or sham acupunctureDocumentation of a diagnostic impression of urge urinary incontinence following urodynamics
Outcome measures
| Measure |
Acupuncture
n=23 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=19 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Urodynamic Impression of Urge Urinary Incontinence
Baseline
|
13 participants
|
13 participants
|
|
Urodynamic Impression of Urge Urinary Incontinence
4-weeks post intervention
|
13 participants
|
10 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)
Glasses/cups per day of non-caffeinated fluids (including water) at baseline
Outcome measures
| Measure |
Acupuncture
n=42 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=58 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)
|
6.88 Glasses/cups per day
Standard Deviation 3.054
|
5.45 Glasses/cups per day
Standard Deviation 2.663
|
SECONDARY outcome
Timeframe: BaselinePopulation: Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)
Duration of urinary incontinence in years
Outcome measures
| Measure |
Acupuncture
n=42 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=58 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years
|
6.93 years
Standard Deviation 6.69
|
10.66 years
Standard Deviation 9.42
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: True and sham acupuncture subjects who completed the 6 weeks of treatment; participants who dropped out of the study during treatment were not included in this analysis
Percentage of acupuncture (true or sham) visits completed as scheduled
Outcome measures
| Measure |
Acupuncture
n=56 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=54 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Adherence to Treatment Protocol
|
91.88 percent of visits
Standard Deviation 9.39
|
91.05 percent of visits
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: 1 week post-treatmentPopulation: The number of participants analyzed for this outcome was only those who completed the treatment protocol and the 1-week post-treatment visit. For this reason, the number is smaller than the number for the primary outcomes
Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.
Outcome measures
| Measure |
Acupuncture
n=53 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=52 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Burden Associated With the Acupuncture Treatment Protocol
|
2.25 units on a scale
Interval 1.5 to 3.25
|
2.25 units on a scale
Interval 1.56 to 3.5
|
SECONDARY outcome
Timeframe: Monthly during the 6 month follow-up periodPopulation: Participants who completed true acupuncture (as either their initial treatment or following sham acupuncture), had a 50% or greater reduction in incontinent episodes at 1 or 4 weeks post-true acupuncture, and completed at least one month of follow-up.
The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.
Outcome measures
| Measure |
Acupuncture
n=51 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Need for Booster Acupuncture During Follow-up
|
43 participants
|
—
|
SECONDARY outcome
Timeframe: After the booster sessionsPopulation: Participants who received booster acupuncture treatments during follow-up
Change in the number of incontinent episodes per day following booster acupuncture
Outcome measures
| Measure |
Acupuncture
n=35 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Response to Booster Acupuncture if Needed
Prior to booster acupuncture
|
1.37 incontinent episodes/day
Standard Deviation 0.97
|
—
|
|
Response to Booster Acupuncture if Needed
Following booster acupuncture
|
0.77 incontinent episodes/day
Standard Deviation 0.69
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 week post true or sham acupunctureChange in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.
Outcome measures
| Measure |
Acupuncture
n=45 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=45 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Pelvic Floor Muscle Strength
|
0.78 seconds
Standard Deviation 4.66
|
0.04 seconds
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post true or sham acupunctureChange in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.
Outcome measures
| Measure |
Acupuncture
n=41 Participants
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=42 Participants
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
Pelvic Floor Muscle Strength
|
0.71 seconds
Standard Deviation 4.98
|
0.53 seconds
Standard Deviation 4.01
|
Adverse Events
Acupuncture
Sham Acupuncture
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture
n=63 participants at risk
Acupuncture: Acupuncture twice weekly for 6 weeks.
|
Sham Acupuncture
n=63 participants at risk
Sham acupuncture: Twice a week for 6 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
33.3%
21/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
25.4%
16/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
General disorders
Drowsy
|
27.0%
17/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
23.8%
15/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Renal and urinary disorders
Increase in incontinent episodes
|
41.3%
26/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
33.3%
21/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Renal and urinary disorders
Increase in urinary urgency
|
31.7%
20/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
28.6%
18/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Renal and urinary disorders
Increase in stress urinary incontinence
|
36.5%
23/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
23.8%
15/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Skin and subcutaneous tissue disorders
Itching at acupuncture site
|
33.3%
21/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
25.4%
16/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
General disorders
Dizzy
|
12.7%
8/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
14.3%
9/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Blood and lymphatic system disorders
Bleeding at acupuncture site
|
65.1%
41/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
3.2%
2/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
General disorders
Pain during treatment
|
81.0%
51/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
34.9%
22/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
General disorders
Aching at needle insertion site(s)
|
65.1%
41/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
22.2%
14/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
|
Blood and lymphatic system disorders
Bruising
|
42.9%
27/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
6.3%
4/63 • 6-weeks; during the intervention period (true and sham acupuncture) adverse events were assessed after each intervention visit
After each visit subjects completed an investigator-developed acupuncture symptom questionnaire. Questions were based on a review of literature reporting adverse effects during acupuncture. Subjects were included if they completed at least one adverse event questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place