Acupuncture for Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Efficacy of Acupuncture in Treating Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297427
• Other study ID #: R01AT002175-01A1
• Secondary ID: R01AT002175-01A1
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2006
• Last updated: June 22, 2012
• Start date: October 2005
• Est. completion date: July 2011

Study information

• Verified date: June 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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. All individuals will be followed for 6 months after completing the acupuncture treatments.

Description:

See Brief Summary

Other known NCT identifiers

• NCT00177450

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• Acupuncture
Acupuncture twice weekly for 6 weeks.

Other:
• Sham acupuncture
Twice a week for 6 weeks

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinent episodes		baseline, 1 and 4 weeks post treatment and monthly during follow-up	No
Primary	Health related quality of life		Baseline, 1 & 4 weeks post-treatment and month 3 and 6 during follow-up	No
Primary	Duration of any beneficial effects		monthly during follow-up	No
Secondary	Bladder capacity		Baseline and 4 weeks post-treatment	No
Secondary	Involuntary bladder contractions		Baseline and 4 weeks post-treatment	No
Secondary	Characteristics of responders		Baseline	No
Secondary	Burden associated with the acupuncture treatment protocol		1 & 4 weeks post-treatment	No
Secondary	Adverse events		After each acupuncture treatment	Yes
Secondary	Need for booster acupuncture during follow-up		Monthly during follow-up	No
Secondary	Response to booster acupuncture if needed		After the booster sessions	No
Secondary	Adherence to the treatment protocol		Weekly during the acupuncture treatment	No
Secondary	Pelvic floor muscle strength		Baseline, 1 & 4 weeks post-treatment and month 3 and 6 during follow-up	No