Complementary and Alternative Medicine for Urological Symptoms(CAMUS)

This study has been completed.
Sponsor:
Collaborators:
Cornell University
New York University
Kaiser Permanente
Northwestern University
Queen's University
University of Colorado, Denver
University of Iowa
University of Maryland
University of Texas
Washington University School of Medicine
Yale University
Information provided by (Responsible Party):
Alan Cantor, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00603304
First received: December 20, 2007
Last updated: September 12, 2012
Last verified: September 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Urological
Interventions: Drug: Saw Palmetto - first 24 weeks
Drug: Placebo - first 24 weeks
Drug: Saw Palmetto - weeks 24 - 48
Drug: Placebo - weeks 24 - 48
Drug: Saw Palmetto - weeks 48 - 72
Drug: Placebo - weeks 48 - 72

  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
A total of 1032 men were prescreened for Complementary and Alternative Medicine for Urological Symptoms (CAMUS), usually by telephone; interested and preliminary eligible men were scheduled for a first screening visit.

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
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Participant Flow:   Overall Study
    Saw Palmetto     Placebo  
STARTED     183     186  
COMPLETED     151     155  
NOT COMPLETED     32     31  
Lost to Follow-up                 5                 7  
Withdrawal by Subject                 8                 5  
Protocol Violation                 1                 0  
Adverse Event                 4                 2  
Unacceptable Treatment Toxicity                 5                 8  
Crossed Over to Open Label Therapy                 3                 3  
Exclusionary Medication                 2                 3  
Non-Compliant                 0                 1  
Moved Away                 0                 2  
Not Specified                 2                 0  
Patient Decision                 2                 0  



  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
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Saw Palmetto     Placebo     Total  
Number of Participants  
[units: participants]
  183     186     369  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     123     125     248  
>=65 years     60     61     121  
Age  
[units: years]
Mean ± Standard Deviation
  61.25  ± 8.72     60.70  ± 8.08     60.86  ± 8.38  
Gender  
[units: participants]
     
Female     0     0     0  
Male     183     186     369  
Region of Enrollment  
[units: participants]
     
United States     167     169     336  
Canada     16     17     33  



  Outcome Measures
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1.  Primary:   Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.   [ Time Frame: Baseline to 72 weeks ]

2.  Secondary:   Participants Global Assessments of Improvement and Satisfaction at End of Study.   [ Time Frame: Baseline to 72 weeks ]

3.  Secondary:   Benign Prostate Hyperplasia (BPH) Impact Index Score   [ Time Frame: Baseline to 72 weeks ]

4.  Secondary:   International Prostate Symptom Score Quality of Life (IPSS QOL) Score   [ Time Frame: Baseline to 72 weeks ]

5.  Secondary:   American Urological Association(AUA) Nocturia Item   [ Time Frame: Baseline to 72 weeks ]

6.  Secondary:   Peak Uroflow   [ Time Frame: Baseline to 72 weeks ]

7.  Secondary:   Post-void Residual   [ Time Frame: Baseline to 72 weeks ]

8.  Secondary:   Prostate Specific Antigen (PSA) Level   [ Time Frame: Baseline to 72 weeks ]

9.  Secondary:   International Index of Erectile Function (IIEF)Scale Score.   [ Time Frame: Baseline to 72 weeks ]

10.  Secondary:   Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.   [ Time Frame: Baseline to 72 weeks. ]

11.  Secondary:   International Continence Society Male Incontinence Symptom (ICSmale IS) Score   [ Time Frame: Baseline to 72 weeks ]

12.  Secondary:   Jenkins Sleep Scale Score   [ Time Frame: Baseline to 72 weeks ]
  Hide Outcome Measure 12

Measure Type Secondary
Measure Title Jenkins Sleep Scale Score
Measure Description The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 – 7 days, three being 8 – 14 days, four being 15 – 21 days, and five being 22 – 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

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.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
  176     181  
Jenkins Sleep Scale Score  
[units: units on a scale]
Mean ( 95% Confidence Interval )
  -0.80  
  ( -1.34 to -0.27 )  
  -1.63  
  ( -2.25 to -1.01 )  

No statistical analysis provided for Jenkins Sleep Scale Score



13.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale   [ Time Frame: Baseline to 72 weeks ]

14.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale   [ Time Frame: Baseline to 72 weeks ]

15.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale   [ Time Frame: Baseline to 72 weeks ]


  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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