Conservative Treatment of Postprostatectomy Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00212264
First received: September 13, 2005
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: October 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Incontinence
Interventions: Behavioral: Behavioral Therapy
Device: Pelvic Floor Electrical Stimulation
Behavioral: Biofeedback
Other: No Treatment

  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
No text entered.

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
Behavioral Therapy

Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)

Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies

Behavioral Therapy Plus Technologies

Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)

Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies

Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks

Biofeedback: Pelvic Floor Muscle training via biofeedback

Placebo Comparator No treatment control

Participant Flow:   Overall Study
    Behavioral Therapy     Behavioral Therapy Plus Technologies     Placebo Comparator  
STARTED     70     70     68  
COMPLETED     58     54     64  
NOT COMPLETED     12     16     4  



  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.
No text entered.

Reporting Groups
  Description
Behavioral Therapy

Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)

Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies

Behavioral Therapy Plus Technologies

Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)

Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies

Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks

Biofeedback: Pelvic Floor Muscle training via biofeedback

Placebo Comparator No treatment control
Total Total of all reporting groups

Baseline Measures
    Behavioral Therapy     Behavioral Therapy Plus Technologies     Placebo Comparator     Total  
Number of Participants  
[units: participants]
  70     70     68     208  
Age  
[units: years]
Mean (Standard Deviation)
  66.3  (7.5)     66.8  (7.0)     66.9  (7.7)     66.7  (7.4)  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     70     70     68     208  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     1     1  
Asian     0     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     19     15     16     50  
White     51     54     50     155  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Incontinence Episodes per Week  
[units: Incontinence Episodes per Week]
Mean (Standard Deviation)
  28.1  (22.0)     25.6  (26.0)     24.8  (19.9)     26.2  (22.6)  



  Outcome Measures
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1.  Primary:   Percent Change in Incontinence Episodes on Bladder Diary   [ Time Frame: 2 months ]

2.  Primary:   Percent Change in Incontinence Episodes Per Week on Bladder Diary   [ Time Frame: 1 year ]


  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: Patricia S Goode, MD
Organization: University of Alabama at Birmingham
phone: 2055587064
e-mail: pgoode@uabmc.edu


Publications of Results:

Responsible Party: Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00212264     History of Changes
Other Study ID Numbers: DK60044 (completed)
Study First Received: September 13, 2005
Results First Received: October 7, 2014
Last Updated: March 21, 2016
Health Authority: United States: Federal Government