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Efficacy of Acupuncture in Treating Urinary Incontinence

This study is currently recruiting participants.
Information provided by University of Pittsburgh

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Descriptive Information Fields
Brief Title  Efficacy of Acupuncture in Treating Urinary Incontinence
Official Title  Efficacy of Acupuncture in Treating Urinary Incontinence
Brief Summary

This study will examine the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women.

Detailed Description

This study will examine the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. Women participating in the study will be randomly assigned to receive either acupuncture of sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body). We will compare the effectiveness of acupuncture and sham (placebo) acupuncture on the frequency and volume of involuntary urine loss after completing the acupuncture and again one month later. Subjects will not know what group they were assigned to until one month after completing the 6-week intervention. Those randomized to the sham (placebo) group will then be eligible to receive the actual acupuncture if they choose to. Subjects will be followed for 7 months following completion of the true acupuncture.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  Urinary accidents [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Health-related quality of life [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
Duration of treatment effects [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Maximal bladder capacity [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
Detrusor instability [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
Subject burden [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Adherence to intervention protocol [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Pelvic floor muscle function [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
Condition  Urinary Incontinence
Stress Urinary Incontinence
Intervention  Procedure: Acupuncture
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  154
Start Date  September 2005
Completion Date August 2011
Eligibility Criteria 

Inclusion Criteria:

(1) 25 years of age and older;(2) ability to read and write English; (3) report being incontinent at least twice a week on average for a period of at least 3 months; (4) document at least two incontinent episodes in a 1-week baseline bladder dairy and (5) urge, stress or mixed urge and stress urinary accidents documented in the 1-week bladder diary.

Exclusion Criteria:

(1) post-void residual urine volume >200 ml;(2) routine use of a catheter, either indwelling or straight for bladder emptying; (3) severe pelvic prolapse reaching the vaginal introitus; (4) history of neurological disorder that may be associated with a neurogenic bladder including Parkinson's disease, multiple sclerosis, spinal injury or a history of stroke with the past 6 months; (5) interstitial cystitis; (6) terminal illness/hospice care; (7) previous acupuncture treatment for any reason;(8) inability to toilet independently; (9) inability/unwillingness to provide adequate self-report bladder diary data after two attempts; (10) inability/unwillingness to complete a 48-hour pad test after two attempts; (11) inability to hear telephone conversation; (12) concurrent treatment of UI with an antimuscarinic agent (subjects must have ceased UI-specific antimuscarinic agents at least two weeks prior to enrollment in the study to allow for a sufficient washout period); (13) diuretic or antihypertensive medication initiated within the past 60 days or whose dose in being adjusted (subjects must be on a stable dose of their diuretic or antihypertensive agent for more than 60 days to be eligible for the study); (14) current treatment with an oral corticosteroid; (15) current treatment with warfarin (there may an increased of bleeding with acupuncture); (16) pregnancy; (17) history of pelvic cancer surgery; (18) history of pelvic radiation; (19) history of urethral diverticulum; (20) history of sacral neuromodulation; (21) history of augmentation cystoplasty; (22) current use of a tricyclic antidepressant; (23) current use of duloxetine; (24) current use of a cholinesterase inhibitor such as Aricept (donepezil hydrochloride); (25) plans to move away from the Allegheny county area during the next year; (26) plans to become pregnant within the next 12 months; (27)inability/unwillingness to have the vaginal electrode inserted, (28) history of dyspareunia and (29) history of severe pelvic pain.

Gender Female
Ages 25 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Sandra J Engberg, PhD     412-624-3835     sje1@pitt.edu    
Contact: Susan M Cohen, DSN     412-625-5345     cohensu@pitt.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00177450
Organization ID 0507028
Secondary IDs †† R01 AT002175
Study Sponsor  University of Pittsburgh
Collaborators †† National Center for Complementary and Alternative Medicine (NCCAM)
Investigators 
Principal Investigator:     Sandra J Engberg, PhD     University of Pittsburgh    
Information Provided By University of Pittsburgh
Verification Date January 2008
First Received Date  September 12, 2005
Last Updated Date January 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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