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
  Purpose

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


Condition Intervention Phase
Urinary Incontinence
Stress Urinary Incontinence
Procedure: Acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture in Treating Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Urinary accidents [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 154
Study Start Date: September 2005
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Procedure: Acupuncture
12 acupuncture sessions over 6 weeks
Sham Comparator: Sham acupuncture Procedure: Acupuncture
12 acupuncture sessions over 6 weeks

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177450

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sandra J Engberg, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Sandra Engberg, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177450     History of Changes
Other Study ID Numbers: 0507028, R01 AT002175
Study First Received: September 12, 2005
Last Updated: February 8, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Urinary incontinence
Urge urinary incontinence
Stress urinary incontinence
Women

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014