We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Urinary Incontinence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297427
First Posted: February 28, 2006
Last Update Posted: October 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sandra Engberg, University of Pittsburgh
Results First Submitted: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Urinary Incontinence
Interventions: Procedure: Acupuncture
Other: Sham acupuncture

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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   54 
NOT COMPLETED   8   9 
Withdrawal by Subject                8                5 
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   54   0 [1] 
Crossed Over to True Acupuncture   42 [2]   0 [1] 
COMPLETED   38   0 [1] 
NOT COMPLETED   16   0 
Withdrawal by Subject                15                0 
Lost to Follow-up                1                0 
[1] There was no cross-over to sham acupuncture as this was a wait list control design
[2] 54 subjects completed the sham acupuncture & were offered the opportunity to cross-over; 12 declined

Period 3:   Phase 3: Follow-up Post-True Acupuncture
    Acupuncture   Sham Acupuncture
STARTED   94   0 [1] 
COMPLETED   60 [2]   0 [1] 
NOT COMPLETED   34   0 
Withdrawal by Subject                29                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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[1] Number of co-morbid health problems
Number of prescription medications [1] 
[Units: Prescription medications]
Mean (Standard Deviation)
 2.20  (2.2)   2.22  (2.33)   2.21  (2.26) 
[1] Number of prescription medications taken on a regular basis
Vaginal deliveries [1] 
[Units: Vaginal deliveries]
Mean (Standard Deviation)
 1.59  (1.51)   1.43  (1.24)   1.51  (1.38) 
[1] Number of vaginal deliveries
Menopausal Status [1] 
[Units: Participants]
     
Postmenopausal   41   43   84 
Premenopausal   23   20   43 
[1] Number of women in each group who self-reported cessation of menses
Hormone replacement therapy [1] 
[Units: Participants]
     
Yes   7   7   14 
No   34   36   70 
No applicable (premenopausal)   23   20   43 
[1] Number of women taking hormone replacement therapy
Limited mobility [1] 
[Units: Participants]
     
Yes   8   9   17 
No   56   54   110 
[1] Number of women with self-reported limitations in mobility
Incontinent episodes/day [1] 
[Units: Episodes/day]
Mean (Standard Deviation)
 2.19  (1.57)   2.59  (2.12)   2.39  (1.87) 
[1] Episodes of urinary incontinence per day as measured by bladder diary
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 [1] 
[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) 
[1] 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.
Physical Health-Related Quality of Life [1] 
[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) 
[1] 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.
Incontinence-Specific Quality of Life [1] 
[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] 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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2006
First Posted: February 28, 2006
Results First Submitted: January 14, 2016
Results First Posted: August 1, 2016
Last Update Posted: October 24, 2016