Urinary Incontinence
Conditions
Keywords
urinary incontinence
Brief summary
This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body) on the frequency and volume of involuntary (accidental) urine loss after completing the intervention, and again one month later. Individuals participating in this study will be randomly assigned to receive either the actual or sham acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study participants will not know which group (actual or sham acupuncture) they were assigned to until one month after completing the 6-weeks of treatment. The sham acupuncture needles look similar to the real acupuncture needles and feel like they penetrate the skin, but do not actually do so. If individuals are assigned to the sham acupuncture group, they will be eligible to receive the actual acupuncture one month after completing the sham acupuncture if they wanted to. All individuals will be followed for 6 months after completing the acupuncture treatments.
Detailed description
See Brief Summary
Interventions
PROCEDUREAcupuncture
Acupuncture twice weekly for 6 weeks.
OTHERSham acupuncture
Twice a week for 6 weeks
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Urge or stress urinary incontinence at least twice a week on average for at least 3 months
Exclusion criteria
* History of previous acupuncture * History of a neurologic problem such as Parkinson's disease or multiple sclerosis that could affect bladder function * Current treatment with overactive bladder medications or medications that relax the bladder * Urinary catheter * Pregnancy * Inability to empty the bladder effectively * Inability to toilet independently * Current treatment with steroid * Interstitial cystitis * Chronic pelvic pain * Current treatment with warfarin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Incontinent Episodes | Baseline to 1 Week post-intervention | Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline. |
| Physical Health-Related Quality of Live | 1 Week post-intervention | 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. |
| Physical Health-Related Quality of Life | 4-weeks post-intervention | 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. |
| Mental Health Related Quality of Life | 1 week post-intervention | 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. |
| Incontinence-Specific Quality of Life | 1 Week post-intervention | 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. |
| Duration of Any Beneficial Effects | monthly during follow-up up to 6 months | Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden Associated With the Acupuncture Treatment Protocol | 1 week post-treatment | 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. |
| Need for Booster Acupuncture During Follow-up | Monthly during the 6 month follow-up period | 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. |
| Change in Bladder Capacity | Change from baseline to 4 weeks post-intervention | Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate. |
| Pelvic Floor Muscle Strength | Baseline and 1 week post true or sham acupuncture | Change 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. |
| Response to Booster Acupuncture if Needed | After the booster sessions | Change in the number of incontinent episodes per day following booster acupuncture |
| Urodynamic Diagnostic Impression of Stress Urinary Incontinence | Baseline and 4 weeks post-treatment | Documentation of a diagnostic impression of stress urinary incontinence following urodynamics |
| Urodynamic Impression of Urge Urinary Incontinence | Baseline and 4 weeks post true or sham acupuncture | Documentation of a diagnostic impression of urge urinary incontinence following urodynamics |
| Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water) | Baseline | Glasses/cups per day of non-caffeinated fluids (including water) at baseline |
| Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | Baseline | Duration of urinary incontinence in years |
| Adherence to Treatment Protocol | 6 weeks | Percentage of acupuncture (true or sham) visits completed as scheduled |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Acupuncture: Acupuncture twice weekly for 6 weeks. | 64 |
| Sham Acupuncture Sham acupuncture: Twice a week for 6 weeks | 63 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1: Initial Intervention | Death | 0 | 1 |
| Phase 1: Initial Intervention | Lost to Follow-up | 0 | 3 |
| Phase 1: Initial Intervention | Withdrawal by Subject | 8 | 5 |
| Phase 2: Optional Crossover for Sham | Lost to Follow-up | 1 | 0 |
| Phase 2: Optional Crossover for Sham | Withdrawal by Subject | 15 | 0 |
| Phase 3: Follow-up Post-True Acupuncture | Could not complete outcome diary | 2 | 0 |
| Phase 3: Follow-up Post-True Acupuncture | Lost to Follow-up | 3 | 0 |
| Phase 3: Follow-up Post-True Acupuncture | Withdrawal by Subject | 29 | 0 |
Baseline characteristics
| Characteristic | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Age, Continuous | 56.31 years STANDARD_DEVIATION 11.93 | 57.41 years STANDARD_DEVIATION 11.86 | 56.86 years STANDARD_DEVIATION 11.86 |
| BMI | 29.47 Kg/m^2 STANDARD_DEVIATION 6.68 | 29.54 Kg/m^2 STANDARD_DEVIATION 6.65 | 29.50 Kg/m^2 STANDARD_DEVIATION 6.64 |
| Co-morbidities | 2.92 co-morbid health problems STANDARD_DEVIATION 2.37 | 2.82 co-morbid health problems STANDARD_DEVIATION 2.09 | 2.87 co-morbid health problems STANDARD_DEVIATION 2.23 |
| Duration of urinary incontinence | 9.81 Years STANDARD_DEVIATION 9.08 | 8.61 Years STANDARD_DEVIATION 9.98 | 9.22 Years STANDARD_DEVIATION 9.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 63 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Hormone replacement therapy No | 34 participants | 36 participants | 70 participants |
| Hormone replacement therapy No applicable (premenopausal) | 23 participants | 20 participants | 43 participants |
| Hormone replacement therapy Yes | 7 participants | 7 participants | 14 participants |
| Incontinence-Specific Quality of Life | 55.95 units on a scale | 61.43 units on a scale | 57.78 units on a scale |
| Incontinent episodes/day | 2.19 episodes/day STANDARD_DEVIATION 1.57 | 2.59 episodes/day STANDARD_DEVIATION 2.12 | 2.39 episodes/day STANDARD_DEVIATION 1.87 |
| Limited mobility No | 56 participants | 54 participants | 110 participants |
| Limited mobility Yes | 8 participants | 9 participants | 17 participants |
| Menopausal Status Postmenopausal | 41 participants | 43 participants | 84 participants |
| Menopausal Status Premenopausal | 23 participants | 20 participants | 43 participants |
| Mental Health-Related Quality of Life | 55.49 units on a scale | 55.90 units on a scale | 55.67 units on a scale |
| Number of prescription medications | 2.20 Prescription medications STANDARD_DEVIATION 2.2 | 2.22 Prescription medications STANDARD_DEVIATION 2.33 | 2.21 Prescription medications STANDARD_DEVIATION 2.26 |
| Physical Health-Related Quality of Life | 54.32 units on a scale | 53.83 units on a scale | 54.17 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 57 Participants | 107 Participants |
| Sex: Female, Male Female | 64 Participants | 63 Participants | 127 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaginal deliveries | 1.59 Vaginal deliveries STANDARD_DEVIATION 1.51 | 1.43 Vaginal deliveries STANDARD_DEVIATION 1.24 | 1.51 Vaginal deliveries STANDARD_DEVIATION 1.38 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 63 | 48 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Duration of Any Beneficial Effects
Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)
Time frame: monthly during follow-up up to 6 months
Population: Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Duration of Any Beneficial Effects | 2.17 Months | Standard Error 0.25 |
Primary
Incontinence-Specific Quality of Life
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.
Time frame: 1 Week post-intervention
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Incontinence-Specific Quality of Life | 26.02 percentage change relative to baseline |
| Sham Acupuncture | Incontinence-Specific Quality of Life | 17.36 percentage change relative to baseline |
p-value: 0.38Wilcoxon (Mann-Whitney)
Primary
Incontinence-Specific Quality of Life
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.
Time frame: 4-weeks post-intervention
Population: Intention-to-treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture | Incontinence-Specific Quality of Life | 48.01 percentage change relative to baseline |
| Sham Acupuncture | Incontinence-Specific Quality of Life | 32.04 percentage change relative to baseline |
p-value: 0.43Wilcoxon (Mann-Whitney)
Primary
Mental Health Related Quality of Life
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.
Time frame: 1 week post-intervention
Population: Intention to treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Mental Health Related Quality of Life | 0 percentage change relative to baseline |
| Sham Acupuncture | Mental Health Related Quality of Life | 2.66 percentage change relative to baseline |
Primary
Mental Health Related Quality of Life
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.
Time frame: 4 weeks post true or sham acupuncture
Population: Intention-to-treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Mental Health Related Quality of Life | 0 percentage change relative to baseline |
| Sham Acupuncture | Mental Health Related Quality of Life | 1.81 percentage change relative to baseline |
p-value: 0.04Wilcoxon (Mann-Whitney)
Primary
Percent Change in Incontinent Episodes
Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.
Time frame: Baseline to 1 Week post-intervention
Population: Intention-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Percent Change in Incontinent Episodes | -38.26 percent change in incontinent episodes | Standard Deviation 42.63 |
| Sham Acupuncture | Percent Change in Incontinent Episodes | -15.29 percent change in incontinent episodes | Standard Deviation 65.41 |
p-value: 0.02t-test, 2 sided
Primary
Percent Change in Incontinent Episodes
Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture
Time frame: 4 weeks post true or sham acupuncture
Population: Intention-to-treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Percent Change in Incontinent Episodes | -42.49 percent change in incontinent episodes | Standard Deviation 40.24 |
| Sham Acupuncture | Percent Change in Incontinent Episodes | -34.47 percent change in incontinent episodes | Standard Deviation 49.98 |
p-value: 0.32t-test, 2 sided
Primary
Physical Health-Related Quality of Life
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.
Time frame: 4-weeks post-intervention
Population: Intention-to-treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Physical Health-Related Quality of Life | 0.37 percentage change relative to baseline |
| Sham Acupuncture | Physical Health-Related Quality of Life | 0 percentage change relative to baseline |
p-value: 0.18Wilcoxon (Mann-Whitney)
Primary
Physical Health-Related Quality of Live
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.
Time frame: 1 Week post-intervention
Population: Intention-to-treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Physical Health-Related Quality of Live | 0 percentage change relative to baseline |
| Sham Acupuncture | Physical Health-Related Quality of Live | 0 percentage change relative to baseline |
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary
Adherence to Treatment Protocol
Percentage of acupuncture (true or sham) visits completed as scheduled
Time frame: 6 weeks
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Adherence to Treatment Protocol | 91.88 percent of visits | Standard Deviation 9.39 |
| Sham Acupuncture | Adherence to Treatment Protocol | 91.05 percent of visits | Standard Deviation 9.28 |
p-value: 0.64t-test, 2 sided
Secondary
Burden Associated With the Acupuncture Treatment Protocol
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.
Time frame: 1 week post-treatment
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Burden Associated With the Acupuncture Treatment Protocol | 2.25 units on a scale |
| Sham Acupuncture | Burden Associated With the Acupuncture Treatment Protocol | 2.25 units on a scale |
p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
Change in Bladder Capacity
Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.
Time frame: Change from baseline to 4 weeks post-intervention
Population: Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Change in Bladder Capacity | 60.45 milliliters | Standard Deviation 114.91 |
| Sham Acupuncture | Change in Bladder Capacity | -17.89 milliliters | Standard Deviation 121.68 |
p-value: 0.04Repeated measures using GEE
Secondary
Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)
Glasses/cups per day of non-caffeinated fluids (including water) at baseline
Time frame: Baseline
Population: Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | 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 |
| Sham Acupuncture | Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water) | 5.45 Glasses/cups per day | Standard Deviation 2.663 |
p-value: 0.04t-test, 2 sided
p-value: 0.01495% CI: [1.039, 1.405]Regression, Logistic
Secondary
Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years
Duration of urinary incontinence in years
Time frame: Baseline
Population: Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | 6.93 years | Standard Deviation 6.69 |
| Sham Acupuncture | Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | 10.66 years | Standard Deviation 9.42 |
p-value: 0.023t-test, 2 sided
p-value: 0.0395% CI: [0.881, 0.994]Regression, Logistic
Secondary
Need for Booster Acupuncture During 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.
Time frame: Monthly during the 6 month follow-up period
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acupuncture | Need for Booster Acupuncture During Follow-up | 43 participants |
Secondary
Pelvic Floor Muscle Strength
Change 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.
Time frame: Baseline and 4 weeks post true or sham acupuncture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Pelvic Floor Muscle Strength | 0.71 seconds | Standard Deviation 4.98 |
| Sham Acupuncture | Pelvic Floor Muscle Strength | 0.53 seconds | Standard Deviation 4.01 |
p-value: 0.86t-test, 2 sided
Secondary
Pelvic Floor Muscle Strength
Change 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.
Time frame: Baseline and 1 week post true or sham acupuncture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Pelvic Floor Muscle Strength | 0.78 seconds | Standard Deviation 4.66 |
| Sham Acupuncture | Pelvic Floor Muscle Strength | 0.04 seconds | Standard Deviation 5.02 |
p-value: 0.48t-test, 2 sided
Secondary
Response to Booster Acupuncture if Needed
Change in the number of incontinent episodes per day following booster acupuncture
Time frame: After the booster sessions
Population: Participants who received booster acupuncture treatments during follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Response to Booster Acupuncture if Needed | Prior to booster acupuncture | 1.37 incontinent episodes/day | Standard Deviation 0.97 |
| Acupuncture | Response to Booster Acupuncture if Needed | Following booster acupuncture | 0.77 incontinent episodes/day | Standard Deviation 0.69 |
p-value: <0.001t-test, 1 sided
Secondary
Urodynamic Diagnostic Impression of Stress Urinary Incontinence
Documentation of a diagnostic impression of stress urinary incontinence following urodynamics
Time frame: Baseline and 4 weeks post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture | Urodynamic Diagnostic Impression of Stress Urinary Incontinence | Baseline | 16 participants |
| Acupuncture | Urodynamic Diagnostic Impression of Stress Urinary Incontinence | 4 weeks post-intervention | 4 participants |
| Sham Acupuncture | Urodynamic Diagnostic Impression of Stress Urinary Incontinence | Baseline | 6 participants |
| Sham Acupuncture | Urodynamic Diagnostic Impression of Stress Urinary Incontinence | 4 weeks post-intervention | 5 participants |
p-value: 0.01Repeated measures using GEE
Secondary
Urodynamic Impression of Urge Urinary Incontinence
Documentation of a diagnostic impression of urge urinary incontinence following urodynamics
Time frame: Baseline and 4 weeks post true or sham acupuncture
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture | Urodynamic Impression of Urge Urinary Incontinence | Baseline | 13 participants |
| Acupuncture | Urodynamic Impression of Urge Urinary Incontinence | 4-weeks post intervention | 13 participants |
| Sham Acupuncture | Urodynamic Impression of Urge Urinary Incontinence | Baseline | 13 participants |
| Sham Acupuncture | Urodynamic Impression of Urge Urinary Incontinence | 4-weeks post intervention | 10 participants |
p-value: 0.41Repeated measures using GEE