Efficacy of Acupuncture in Treating Urinary Incontinence
Tracking Information | |||||
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | February 8, 2011 | ||||
Start Date ICMJE | September 2005 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Urinary accidents [ Time Frame: 10 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00177450 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy of Acupuncture in Treating Urinary Incontinence | ||||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Acupuncture
12 acupuncture sessions over 6 weeks |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 154 | ||||
Estimated Completion Date | August 2011 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. |
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Gender | Female | ||||
Ages | 25 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177450 | ||||
Other Study ID Numbers ICMJE | 0507028, R01 AT002175 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Sandra Engberg, University of Pittsburgh | ||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
Investigators ICMJE |
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Information Provided By | University of Pittsburgh | ||||
Verification Date | February 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |