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
  Show All Outcome Measures

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 ]

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
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Time Frame Collected over 72 weeks
Additional Description The number of participants at risk was determined by the number of participants that were randomized and included in the modified intention to treat analyses.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
Saw Palmetto One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
Placebo One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.

Other Adverse Events
    Saw Palmetto     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     138/176     139/181  
Gastrointestinal disorders      
Diarrhea *    
# participants affected / at risk     14/176 (7.95%)     8/181 (4.42%)  
# events     14     8  
Constipation *    
# participants affected / at risk     7/176 (3.98%)     7/181 (3.87%)  
# events     7     7  
Hemorrhoids *    
# participants affected / at risk     1/176 (0.57%)     1/181 (0.55%)  
# events     1     1  
Hernia *    
# participants affected / at risk     1/176 (0.57%)     3/181 (1.66%)  
# events     1     3  
Reflux *    
# participants affected / at risk     4/176 (2.27%)     5/181 (2.76%)  
# events     4     5  
Abdominal Pains *    
# participants affected / at risk     1/176 (0.57%)     2/181 (1.10%)  
# events     1     2  
Rectal Bleed *    
# participants affected / at risk     1/176 (0.57%)     2/181 (1.10%)  
# events     1     2  
Gastroenteritis *    
# participants affected / at risk     4/176 (2.27%)     1/181 (0.55%)  
# events     4     1  
Barrett's Esophagus *    
# participants affected / at risk     3/176 (1.70%)     0/181 (0.00%)  
# events     3     0  
Flatulence *    
# participants affected / at risk     2/176 (1.14%)     3/181 (1.66%)  
# events     2     3  
Nausea *    
# participants affected / at risk     4/176 (2.27%)     4/181 (2.21%)  
# events     4     4  
Fatty Liver *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Diverticulitis *    
# participants affected / at risk     3/176 (1.70%)     2/181 (1.10%)  
# events     3     2  
Dysphagia *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Esophagitis *    
# participants affected / at risk     2/176 (1.14%)     0/181 (0.00%)  
# events     2     0  
Bloating *    
# participants affected / at risk     1/176 (0.57%)     2/181 (1.10%)  
# events     1     2  
White Stool *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Upset Stomach/Flu *    
# participants affected / at risk     1/176 (0.57%)     9/181 (4.97%)  
# events     1     9  
Appendicitis *    
# participants affected / at risk     0/176 (0.00%)     2/181 (1.10%)  
# events     0     2  
Black Stool *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Colon Polyp *    
# participants affected / at risk     0/176 (0.00%)     2/181 (1.10%)  
# events     0     2  
Emesis *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Irritable Bowel Syndrome *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Anal Itching *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
Back Pain *    
# participants affected / at risk     11/176 (6.25%)     13/181 (7.18%)  
# events     11     13  
Knee Pain *    
# participants affected / at risk     11/176 (6.25%)     7/181 (3.87%)  
# events     11     7  
Gout *    
# participants affected / at risk     1/176 (0.57%)     5/181 (2.76%)  
# events     1     5  
Foot Pain *    
# participants affected / at risk     1/176 (0.57%)     8/181 (4.42%)  
# events     1     8  
Tendonitis *    
# participants affected / at risk     2/176 (1.14%)     0/181 (0.00%)  
# events     2     0  
Muscle Spasms *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Hip Pain *    
# participants affected / at risk     6/176 (3.41%)     2/181 (1.10%)  
# events     6     2  
Shoulder Pain *    
# participants affected / at risk     8/176 (4.55%)     10/181 (5.52%)  
# events     8     10  
Elbow Pain *    
# participants affected / at risk     4/176 (2.27%)     2/181 (1.10%)  
# events     4     2  
Broken Tooth *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Chest Discomfort *    
# participants affected / at risk     2/176 (1.14%)     1/181 (0.55%)  
# events     2     1  
Bursitis *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Arthritis *    
# participants affected / at risk     2/176 (1.14%)     1/181 (0.55%)  
# events     2     1  
Cyst *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Osteoporosis *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Hernia *    
# participants affected / at risk     2/176 (1.14%)     2/181 (1.10%)  
# events     2     2  
Facial Edema *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
C-Spine Degenerative Disease *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Bruised Ribs/Pain *    
# participants affected / at risk     2/176 (1.14%)     0/181 (0.00%)  
# events     2     0  
Flank Pain *    
# participants affected / at risk     3/176 (1.70%)     0/181 (0.00%)  
# events     3     0  
Joint Pain *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Fore Arm Pain *    
# participants affected / at risk     2/176 (1.14%)     2/181 (1.10%)  
# events     2     2  
Lump in Right Calf *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Neck Pain *    
# participants affected / at risk     3/176 (1.70%)     3/181 (1.66%)  
# events     3     3  
Spinal Stenosis *    
# participants affected / at risk     2/176 (1.14%)     0/181 (0.00%)  
# events     2     0  
Hand Pain *    
# participants affected / at risk     3/176 (1.70%)     1/181 (0.55%)  
# events     3     1  
Plantar Fascitis *    
# participants affected / at risk     1/176 (0.57%)     1/181 (0.55%)  
# events     1     1  
Toe Surgery *    
# participants affected / at risk     1/176 (0.57%)     1/181 (0.55%)  
# events     1     1  
Leg Pain *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Knee Replacement *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Groin Pain *    
# participants affected / at risk     0/176 (0.00%)     4/181 (2.21%)  
# events     0     4  
Osteopenia *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Jaw Pain *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Sciatic Nerve Pain *    
# participants affected / at risk     0/176 (0.00%)     3/181 (1.66%)  
# events     0     3  
Sore Coccyx *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Wrist Surgery *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Renal and urinary disorders      
Hematuria *    
# participants affected / at risk     2/176 (1.14%)     1/181 (0.55%)  
# events     2     1  
Nocturia *    
# participants affected / at risk     10/176 (5.68%)     7/181 (3.87%)  
# events     10     7  
Decreased Libido *    
# participants affected / at risk     3/176 (1.70%)     3/181 (1.66%)  
# events     3     3  
Kidney Stones *    
# participants affected / at risk     1/176 (0.57%)     4/181 (2.21%)  
# events     1     4  
Elevated PSA *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Testicular Pain *    
# participants affected / at risk     2/176 (1.14%)     2/181 (1.10%)  
# events     2     2  
Tip of Penis Swollen *    
# participants affected / at risk     2/176 (1.14%)     0/181 (0.00%)  
# events     2     0  
BPH Symptoms *    
# participants affected / at risk     27/176 (15.34%)     33/181 (18.23%)  
# events     27     33  
Pain in Groin *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Incontinence *    
# participants affected / at risk     3/176 (1.70%)     2/181 (1.10%)  
# events     3     2  
Prostatitis *    
# participants affected / at risk     2/176 (1.14%)     2/181 (1.10%)  
# events     2     2  
Small Spermatocele found in physical exam *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Prostate nodule left lobe *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Peyronies Disease *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Urinary Tract Infection *    
# participants affected / at risk     1/176 (0.57%)     1/181 (0.55%)  
# events     1     1  
Increase Firmness Erection *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Anal Itching *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Epididymitis *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Increased PVR *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Trace WBC in Urine *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Urological Disorder - Bloating *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Bronchitis *    
# participants affected / at risk     4/176 (2.27%)     3/181 (1.66%)  
# events     4     3  
Cold *    
# participants affected / at risk     23/176 (13.07%)     19/181 (10.50%)  
# events     23     19  
Frost bite to bronchial tubes *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Increase mucus *    
# participants affected / at risk     1/176 (0.57%)     0/181 (0.00%)  
# events     1     0  
Strep Throat *    
# participants affected / at risk     1/176 (0.57%)     1/181 (0.55%)  
# events     1     1  
Pharyngitis *    
# participants affected / at risk     1/176 (0.57%)     2/181 (1.10%)  
# events     1     2  
Congestion *    
# participants affected / at risk     3/176 (1.70%)     1/181 (0.55%)  
# events     3     1  
Sinus Infection *    
# participants affected / at risk     9/176 (5.11%)     12/181 (6.63%)  
# events     9     12  
Sneezing *    
# participants affected / at risk     9/176 (5.11%)     0/181 (0.00%)  
# events     9     0  
Sore Throat *    
# participants affected / at risk     2/176 (1.14%)     2/181 (1.10%)  
# events     2     2  
Respiratory Infection *    
# participants affected / at risk     2/176 (1.14%)     10/181 (5.52%)  
# events     2     10  
Rhinitis *    
# participants affected / at risk     0/176 (0.00%)     2/181 (1.10%)  
# events     0     2  
Rhinorrhea *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Post Nasal Drip *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Pre-Existing Lower Back Pain *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Tonsilectomy and Deviated Septum Repair *    
# participants affected / at risk     0/176 (0.00%)     1/181 (0.55%)  
# events     0     1  
Cough *    
# participants affected / at risk     5/176 (2.84%)     5/181 (2.76%)  
# events     5     5  
* Events were collected by non-systematic assessment



  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
No text entered.


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