Efficacy of Acupuncture in Treating Urinary Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177450
First received: September 12, 2005
Last updated: February 8, 2011
Last verified: February 2011

September 12, 2005
February 8, 2011
September 2005
December 2010   (final data collection date for primary outcome measure)
Urinary accidents [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Urinary accidents
  • Health-related quality of life
  • Duration of treatment effects
Complete list of historical versions of study NCT00177450 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health related quality of life [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Duration of treatment effect [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Maximal bladder capacity
  • Detrusor instability
  • Subject burden
  • Adverse events
  • Adherence to intervention protocol
  • Pelvic floor muscle function
Not Provided
Not Provided
 
Efficacy of Acupuncture in Treating Urinary Incontinence
Efficacy of Acupuncture in Treating Urinary Incontinence

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Stress Urinary Incontinence
Procedure: Acupuncture
12 acupuncture sessions over 6 weeks
  • Experimental: Acupuncture
    Intervention: Procedure: Acupuncture
  • Sham Comparator: Sham acupuncture
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
154
August 2011
December 2010   (final data collection date for primary outcome measure)

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.

Female
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177450
0507028, R01 AT002175
Yes
Sandra Engberg, University of Pittsburgh
University of Pittsburgh
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Sandra J Engberg, PhD University of Pittsburgh
University of Pittsburgh
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP