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Acupuncture for Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sandra Engberg, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00297427
First received: February 24, 2006
Last updated: June 20, 2016
Last verified: June 2016
Results First Received: January 14, 2016  
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
Condition: Urinary Incontinence
Interventions: Procedure: Acupuncture
Other: Sham acupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Acupuncture Acupuncture: Acupuncture twice weekly for 6 weeks.
Sham Acupuncture Sham acupuncture: Twice a week for 6 weeks

Participant Flow for 3 periods

Period 1:   Phase 1: Initial Intervention
    Acupuncture     Sham Acupuncture  
STARTED     64 [1]   63 [1]
COMPLETED     56     53  
NOT COMPLETED     8     10  
Withdrawal by Subject                 8                 6  
Lost to Follow-up                 0                 3  
Death                 0                 1  
[1] Intention-to-treat analysis; all randomized subjects were included in analysis

Period 2:   Phase 2: Optional Crossover for Sham
    Acupuncture     Sham Acupuncture  
STARTED     53     0 [1]
Crossed Over to True Acupuncture     53     0 [1]
COMPLETED     33     0 [1]
NOT COMPLETED     20     0  
Withdrawal by Subject                 19                 0  
Lost to Follow-up                 1                 0  
[1] There was no cross-over to sham acupuncture as this was a wait list control design

Period 3:   Phase 3: Follow-up Post-True Acupuncture
    Acupuncture     Sham Acupuncture  
STARTED     89     0 [1]
COMPLETED     65 [2]   0 [1]
NOT COMPLETED     24     0  
Withdrawal by Subject                 19                 0  
Lost to Follow-up                 3                 0  
Could not complete outcome diary                 2                 0  
[1] Only subjects who received true acupuncture initially or after cross-over entered follow-up
[2] Subjects who completed=/>1 follow-up visits and were evaluated for booster acupuncture



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Acupuncture Acupuncture: Acupuncture twice weekly for 6 weeks.
Sham Acupuncture Sham acupuncture: Twice a week for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Acupuncture     Sham Acupuncture     Total  
Number of Participants  
[units: participants]
  64     63     127  
Age  
[units: years]
Mean (Standard Deviation)
  56.31  (11.93)     57.41  (11.86)     56.86  (11.86)  
Gender  
[units: participants]
     
Female     64     63     127  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     62     63     125  
Unknown or Not Reported     2     0     2  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     9     5     14  
White     50     57     107  
More than one race     3     1     4  
Unknown or Not Reported     2     0     2  
BMI  
[units: Kg/m^2]
Mean (Standard Deviation)
  29.47  (6.68)     29.54  (6.65)     29.50  (6.64)  
Co-morbidities [1]
[units: co-morbid health problems]
Mean (Standard Deviation)
  2.92  (2.37)     2.82  (2.09)     2.87  (2.23)  
Number of prescription medications [2]
[units: Prescription medications]
Mean (Standard Deviation)
  2.20  (2.2)     2.22  (2.33)     2.21  (2.26)  
Vaginal deliveries [3]
[units: Vaginal deliveries]
Mean (Standard Deviation)
  1.59  (1.51)     1.43  (1.24)     1.51  (1.38)  
Menopausal Status [4]
[units: participants]
     
Postmenopausal     41     43     84  
Premenopausal     23     20     43  
Hormone replacement therapy [5]
[units: participants]
     
Yes     7     7     14  
No     34     36     70  
No applicable (premenopausal)     23     20     43  
Limited mobility [6]
[units: participants]
     
Yes     8     9     17  
No     56     54     110  
Incontinent episodes/day [7]
[units: episodes/day]
Mean (Standard Deviation)
  2.19  (1.57)     2.59  (2.12)     2.39  (1.87)  
Duration of urinary incontinence  
[units: Years]
Mean (Standard Deviation)
  9.81  (9.08)     8.61  (9.98)     9.22  (9.52)  
Mental Health-Related Quality of Life [8]
[units: units on a scale]
Median (Inter-Quartile Range)
  55.49  
  (48.03 to 58.99)  
  55.90  
  (49.22 to 60.52)  
  55.67  
  (49.22 to 59.42)  
Physical Health-Related Quality of Life [9]
[units: units on a scale]
Median (Inter-Quartile Range)
  54.32  
  (48.03 to 57.19)  
  53.83  
  (48.47 to 56.80)  
  54.17  
  (48.34 to 57.08)  
Incontinence-Specific Quality of Life [10]
[units: units on a scale]
Median (Inter-Quartile Range)
  55.95  
  (27.94 to 121.88)  
  61.43  
  (20.63 to 118.78)  
  57.78  
  (25.56 to 118.78)  
[1] Number of co-morbid health problems
[2] Number of prescription medications taken on a regular basis
[3] Number of vaginal deliveries
[4] Number of women in each group who self-reported cessation of menses
[5] Number of women taking hormone replacement therapy
[6] Number of women with self-reported limitations in mobility
[7] Episodes of urinary incontinence per day as measured by bladder diary
[8] Measured by the Medical Outcomes Short Form-36 (SF-36) where higher scores indicate better quality of life. The possible score range is 0 to 100.
[9] Measured by the Medical Outcomes Study Short Form-36 (SF-36) where higher scores indicate better quality of life. Possible score range is 0 to 100.
[10] Measured by the Incontinence Impact Questionnaire total score. Possible scores range from 0 to 300 with higher scored indicating worse urinary-specific quality of life.



  Outcome Measures
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1.  Primary:   Percent Change in Incontinent Episodes   [ Time Frame: Baseline to 1 Week post-intervention ]

2.  Primary:   Percent Change in Incontinent Episodes   [ Time Frame: 4 weeks post true or sham acupuncture ]

3.  Primary:   Physical Health-Related Quality of Live   [ Time Frame: 1 Week post-intervention ]

4.  Primary:   Physical Health-Related Quality of Life   [ Time Frame: 4-weeks post-intervention ]

5.  Primary:   Mental Health Related Quality of Life   [ Time Frame: 1 week post-intervention ]

6.  Primary:   Mental Health Related Quality of Life   [ Time Frame: 4 weeks post true or sham acupuncture ]

7.  Primary:   Incontinence-Specific Quality of Life   [ Time Frame: 1 Week post-intervention ]

8.  Primary:   Incontinence-Specific Quality of Life   [ Time Frame: 4-weeks post-intervention ]

9.  Primary:   Duration of Any Beneficial Effects   [ Time Frame: monthly during follow-up up to 6 months ]

10.  Secondary:   Change in Bladder Capacity   [ Time Frame: Change from baseline to 4 weeks post-intervention ]

11.  Secondary:   Urodynamic Diagnostic Impression of Stress Urinary Incontinence   [ Time Frame: Baseline and 4 weeks post-treatment ]

12.  Secondary:   Urodynamic Impression of Urge Urinary Incontinence   [ Time Frame: Baseline and 4 weeks post true or sham acupuncture ]

13.  Secondary:   Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)   [ Time Frame: Baseline ]

14.  Secondary:   Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years   [ Time Frame: Baseline ]

15.  Secondary:   Adherence to Treatment Protocol   [ Time Frame: 6 weeks ]

16.  Secondary:   Burden Associated With the Acupuncture Treatment Protocol   [ Time Frame: 1 week post-treatment ]

17.  Secondary:   Need for Booster Acupuncture During Follow-up   [ Time Frame: Monthly during the 6 month follow-up period ]

18.  Secondary:   Response to Booster Acupuncture if Needed   [ Time Frame: After the booster sessions ]

19.  Secondary:   Pelvic Floor Muscle Strength   [ Time Frame: Baseline and 1 week post true or sham acupuncture ]

20.  Secondary:   Pelvic Floor Muscle Strength   [ Time Frame: Baseline and 4 weeks post true or sham acupuncture ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sandra Engberg
Organization: University of Pittsburgh
phone: 412-624-6616
e-mail: sje1@pitt.edu



Responsible Party: Sandra Engberg, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00297427     History of Changes
Obsolete Identifiers: NCT00177450
Other Study ID Numbers: R01AT002175-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 24, 2006
Results First Received: January 14, 2016
Last Updated: June 20, 2016
Health Authority: United States: Federal Government