Phase 2 N=127 Randomized Triple-blind Treatment

Acupuncture for Urinary Incontinence

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT00297427 ↗

Enrolled (actual)

127

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Percent Change in Incontinent Episodes — -38.26; -15.29 percent change in incontinent episodes — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acupuncture (Procedure); Sham acupuncture (Other)
Age: Adult, Older Adult · 25+ yrs
Sex: Female
Sponsor: University of Pittsburgh
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Incontinent Episodes	-42.49; -34.47	0.32
PRIMARY Percent Change in Incontinent Episodes	-42.49; -34.47	0.32
PRIMARY Physical Health-Related Quality of Live	0; 0	0.16
PRIMARY Physical Health-Related Quality of Life	0.37; 0	0.18
PRIMARY Mental Health Related Quality of Life	0; 1.81	0.04 sig
PRIMARY Mental Health Related Quality of Life	0; 1.81	0.04 sig
PRIMARY Incontinence-Specific Quality of Life	48.01; 32.04	0.43
PRIMARY Incontinence-Specific Quality of Life	48.01; 32.04	0.43
PRIMARY Duration of Any Beneficial Effects	2.17	—
SECONDARY Change in Bladder Capacity	60.45; -17.89	0.04 sig
SECONDARY Urodynamic Diagnostic Impression of Stress Urinary Incontinence	16; 6; 4; 5	0.01 sig
SECONDARY Urodynamic Impression of Urge Urinary Incontinence	13; 13; 13; 10	0.41
SECONDARY Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)	6.88; 5.45	0.04 sig
SECONDARY Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years	6.93; 10.66	0.023 sig
SECONDARY Adherence to Treatment Protocol	91.88; 91.05	0.64
SECONDARY Burden Associated With the Acupuncture Treatment Protocol	2.25; 2.25	0.78
SECONDARY Need for Booster Acupuncture During Follow-up	43	—
SECONDARY Response to Booster Acupuncture if Needed	1.37; 0.77	<.001 sig
SECONDARY Pelvic Floor Muscle Strength	0.71; 0.53	0.86
SECONDARY Pelvic Floor Muscle Strength	0.71; 0.53	0.86

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00297427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.