| ID | Type | Description | Link |
|---|---|---|---|
| R01AT002175-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
See Brief Summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Subjects will 12 acupuncture treatments over 6 weeks; treatment sessions occur twice a week. A total of 12 acupuncture needles will be inserted bilaterally at two leg points and four back points. Needles are manually inserted through a standard guide tube contained within a fitted sheath and the basal ring secured to the skin by double-sided tape. The needles remain in place for 25 minutes and are manually stimulated twice during each treatment. |
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| Sham acupuncture | Sham Comparator | Subjects will receive 12 sham acupuncture treatments (delivered twice a week) over 6 weeks. The sham needle is blunted needle whose shaft telescopes into the handle when tapped. While the needle appears to have been inserted, it does not actually penetrate the skin. It is held in place by the same standard guide tube used in the true acupuncture group. The acupuncture points and duration of treatment are the same as for the true acupuncture group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture twice weekly for 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 1 Week post-intervention |
| Percent Change in Incontinent Episodes | Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture | 4 weeks post true or sham acupuncture |
| 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. | 1 Week post-intervention |
| 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. | 4-weeks post-intervention |
| 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. | 1 week post-intervention |
| Mental Health Related Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bladder Capacity | Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate. | Change from baseline to 4 weeks post-intervention |
| Urodynamic Diagnostic Impression of Stress Urinary Incontinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Engberg, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Acupuncture: Acupuncture twice weekly for 6 weeks. |
| FG001 | Sham Acupuncture | Sham acupuncture: Twice a week for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Initial Intervention |
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| Phase 2: Optional Crossover for Sham |
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| Phase 3: Follow-up Post-True Acupuncture |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Acupuncture: Acupuncture twice weekly for 6 weeks. |
| BG001 | Sham Acupuncture | Sham acupuncture: Twice a week for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat | Posted | Mean | Standard Deviation | percent change in incontinent episodes | Baseline to 1 Week post-intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Acupuncture: Acupuncture twice weekly for 6 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Reported feeling tired during or after at least one acupuncture (true or sham) treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra Engberg | University of Pittsburgh | 412-624-6616 | sje1@pitt.edu |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture |
| Other |
Twice a week for 6 weeks |
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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. |
| 4 weeks post true or sham acupuncture |
| 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. | 1 Week post-intervention |
| 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. | 4-weeks post-intervention |
| 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) | monthly during follow-up up to 6 months |
Documentation of a diagnostic impression of stress urinary incontinence following urodynamics |
| Baseline and 4 weeks post-treatment |
| Urodynamic Impression of Urge Urinary Incontinence | Documentation of a diagnostic impression of urge urinary incontinence following urodynamics | Baseline and 4 weeks post true or sham acupuncture |
| 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 | Baseline |
| Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | Duration of urinary incontinence in years | Baseline |
| Adherence to Treatment Protocol | Percentage of acupuncture (true or sham) visits completed as scheduled | 6 weeks |
| 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. | 1 week post-treatment |
| 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. | Monthly during the 6 month follow-up period |
| Response to Booster Acupuncture if Needed | Change in the number of incontinent episodes per day following booster acupuncture | After the booster sessions |
| 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. | Baseline and 1 week post true or sham acupuncture |
| 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. | Baseline and 4 weeks post true or sham acupuncture |
| Death |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | Kg/m^2 |
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| Co-morbidities | Number of co-morbid health problems | Mean | Standard Deviation | co-morbid health problems |
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| Number of prescription medications | Number of prescription medications taken on a regular basis | Mean | Standard Deviation | Prescription medications |
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| Vaginal deliveries | Number of vaginal deliveries | Mean | Standard Deviation | Vaginal deliveries |
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| Menopausal Status | Number of women in each group who self-reported cessation of menses | Number | participants |
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| Hormone replacement therapy | Number of women taking hormone replacement therapy | Number | participants |
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| Limited mobility | Number of women with self-reported limitations in mobility | Number | participants |
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| Incontinent episodes/day | Episodes of urinary incontinence per day as measured by bladder diary | Mean | Standard Deviation | episodes/day |
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| Duration of urinary incontinence | Mean | Standard Deviation | Years |
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| Mental Health-Related Quality of Life | Measured by the Medical Outcomes Short Form-36 (SF-36) where higher scores indicate better quality of life. The possible score range is 0 to 100. | Median | Inter-Quartile Range | units on a scale |
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| Physical Health-Related Quality of Life | Measured by the Medical Outcomes Study Short Form-36 (SF-36) where higher scores indicate better quality of life. Possible score range is 0 to 100. | Median | Inter-Quartile Range | units on a scale |
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| Incontinence-Specific Quality of Life | Measured by the Incontinence Impact Questionnaire total score. Possible scores range from 0 to 300 with higher scored indicating worse urinary-specific quality of life. | Median | Inter-Quartile Range | units on a scale |
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Intention-to-treat analysis | Posted | Mean | Standard Deviation | percent change in incontinent episodes | 4 weeks post true or sham acupuncture |
|
|
|
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| 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. | Intention-to-treat | Posted | Median | Inter-Quartile Range | percentage change relative to baseline | 1 Week post-intervention |
|
|
|
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| 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. | Intention-to-treat | Posted | Median | Inter-Quartile Range | percentage change relative to baseline | 4-weeks post-intervention |
|
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|
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| 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. | Intention to treat analysis | Posted | Median | Inter-Quartile Range | percentage change relative to baseline | 1 week post-intervention |
|
|
|
| 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. | Intention-to-treat | Posted | Median | Inter-Quartile Range | percentage change relative to baseline | 4 weeks post true or sham acupuncture |
|
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| 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. | Intention-to-treat analysis | Posted | Median | Inter-Quartile Range | percentage change relative to baseline | 1 Week post-intervention |
|
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| 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. | Intention-to-treat | Posted | Mean | Inter-Quartile Range | percentage change relative to baseline | 4-weeks post-intervention |
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| 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) | Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture | Posted | Mean | Standard Error | Months | monthly during follow-up up to 6 months |
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| Secondary | Change in Bladder Capacity | Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate. | Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture. | Posted | Mean | Standard Deviation | milliliters | Change from baseline to 4 weeks post-intervention |
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| Secondary | Urodynamic Diagnostic Impression of Stress Urinary Incontinence | Documentation of a diagnostic impression of stress urinary incontinence following urodynamics | Posted | Number | participants | Baseline and 4 weeks post-treatment |
|
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| Secondary | Urodynamic Impression of Urge Urinary Incontinence | Documentation of a diagnostic impression of urge urinary incontinence following urodynamics | Posted | Number | participants | Baseline and 4 weeks post true or sham acupuncture |
|
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|
| 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 | Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention) | Posted | Mean | Standard Deviation | Glasses/cups per day | Baseline |
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| Secondary | Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | Duration of urinary incontinence in years | Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention) | Posted | Mean | Standard Deviation | years | Baseline |
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| Secondary | Adherence to Treatment Protocol | Percentage of acupuncture (true or sham) visits completed as scheduled | 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 | Posted | Mean | Standard Deviation | percent of visits | 6 weeks |
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| 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. | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 1 week post-treatment |
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| 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. | 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. | Posted | Number | participants | Monthly during the 6 month follow-up period |
|
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| Secondary | Response to Booster Acupuncture if Needed | Change in the number of incontinent episodes per day following booster acupuncture | Participants who received booster acupuncture treatments during follow-up | Posted | Mean | Standard Deviation | incontinent episodes/day | After the booster sessions |
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| 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. | Posted | Mean | Standard Deviation | seconds | Baseline and 1 week post true or sham acupuncture |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | seconds | Baseline and 4 weeks post true or sham acupuncture |
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| 0 |
| 63 |
| 56 |
| 63 |
| EG001 | Sham Acupuncture | Sham acupuncture: Twice a week for 6 weeks | 0 | 63 | 48 | 63 |
|
| Drowsy | General disorders | Systematic Assessment | Reported feeling drowsy during or after at least acupuncture (true or sham) treatment |
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| Increase in incontinent episodes | Renal and urinary disorders | Systematic Assessment | Reported experiencing an increase in urinary incontinent episodes after at least one acupuncture (true or sham) treatment |
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| Increase in urinary urgency | Renal and urinary disorders | Systematic Assessment | Reported an increase in urinary urgency after at least one acupuncture (true or sham) treatment |
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| Increase in stress urinary incontinence | Renal and urinary disorders | Systematic Assessment | Reported an increase in urinary leakage with physical activity after at least one acupuncture (true or sham) treatment |
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| Itching at acupuncture site | Skin and subcutaneous tissue disorders | Systematic Assessment | Reported itching at the acupuncture site after at least one acupuncture (true or sham) treatment |
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| Dizzy | General disorders | Systematic Assessment | Reported feeling dizzy during or after at least one acupuncture (true or sham) treatment |
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| Bleeding at acupuncture site | Blood and lymphatic system disorders | Systematic Assessment | Reported any bleeding at any of the acupuncture sites during or after an acupuncture (true or sham) treatment |
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| Pain during treatment | General disorders | Systematic Assessment | Pain during needle insertion reported during at least one acupuncture (true or sham) treatment |
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| Aching at needle insertion site(s) | General disorders | Systematic Assessment | Reported aching at any needle insertion site after at least one acupuncture (true or sham) treatment |
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| Bruising | Blood and lymphatic system disorders | Systematic Assessment | Reported bruising at a needle insertion site after at least one acupuncture (true or sham) treatment |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Odds Ratio (OR) |
| 1.208 |
| 2-Sided |
| 95 |
| 1.039 |
| 1.405 |
These are the adjusted results of a multivariate logistic regression. |
| No |
| Superiority or Other |
| 0.030 |
| Odds Ratio (OR) |
| 0.936 |
| 2-Sided |
| 95 |
| 0.881 |
| 0.994 |
These are the adjusted results from a multivariate logistic regression analysis. |
| No |
| Superiority or Other |