Clinical trial NCT00297427: Acupuncture for Urinary Incontinence
Official title: Efficacy of Acupuncture in Treating Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: urinary incontinence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-02-28
Enrollment: 127
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Incontinent Episodes
timeFrame: Baseline to 1 Week post-intervention
measure: Percent Change in Incontinent Episodes
timeFrame: 4 weeks post true or sham acupuncture
measure: Physical Health-Related Quality of Live
timeFrame: 1 Week post-intervention
measure: Physical Health-Related Quality of Life
timeFrame: 4-weeks post-intervention
measure: Mental Health Related Quality of Life
timeFrame: 1 week post-intervention
measure: Mental Health Related Quality of Life
timeFrame: 4 weeks post true or sham acupuncture
measure: Incontinence-Specific Quality of Life
timeFrame: 1 Week post-intervention
measure: Incontinence-Specific Quality of Life
timeFrame: 4-weeks post-intervention
measure: Duration of Any Beneficial Effects
timeFrame: monthly during follow-up up to 6 months
Secondary outcomes:
measure: Change in Bladder Capacity
timeFrame: Change from baseline to 4 weeks post-intervention
measure: Urodynamic Diagnostic Impression of Stress Urinary Incontinence
timeFrame: Baseline and 4 weeks post-treatment
measure: Urodynamic Impression of Urge Urinary Incontinence
timeFrame: Baseline and 4 weeks post true or sham acupuncture
measure: Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)
timeFrame: Baseline
measure: Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years
timeFrame: Baseline
measure: Adherence to Treatment Protocol
timeFrame: 6 weeks
measure: Burden Associated With the Acupuncture Treatment Protocol
timeFrame: 1 week post-treatment
measure: Need for Booster Acupuncture During Follow-up
timeFrame: Monthly during the 6 month follow-up period
measure: Response to Booster Acupuncture if Needed
timeFrame: After the booster sessions
measure: Pelvic Floor Muscle Strength
timeFrame: Baseline and 1 week post true or sham acupuncture
measure: Pelvic Floor Muscle Strength
timeFrame: Baseline and 4 weeks post true or sham acupuncture
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandra Engberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: