Trial · NCT00603304
Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
NCT00603304, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2012-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Complementary and Alternative Medicine for Urological Symptoms(CAMUS). Trials, record NCT00603304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
- NCT number
- NCT00603304
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 369 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Urological
- Interventions
- Saw Palmetto - first 24 weeks, Placebo - first 24 weeks, Saw Palmetto - weeks 24 - 48, Placebo - weeks 24 - 48, Saw Palmetto - weeks 48 - 72, Placebo - weeks 48 - 72
- First posted
- 2008-01-29
- Last updated
- 2012-10-12
- Results first posted
- 2012-10-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | Baseline to 72 weeks | The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. |
| Secondary | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Baseline to 72 weeks | Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes. |
| Secondary | Benign Prostate Hyperplasia (BPH) Impact Index Score | Baseline to 72 weeks | The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction. |
| Secondary | International Prostate Symptom Score Quality of Life (IPSS QOL) Score | Baseline to 72 weeks | The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction. |
| Secondary | American Urological Association(AUA) Nocturia Item | Baseline to 72 weeks | The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction. |
| Secondary | Peak Uroflow | Baseline to 72 weeks | The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction. |
| Secondary | Post-void Residual | Baseline to 72 weeks | The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction. |
| Secondary | Prostate Specific Antigen (PSA) Level | Baseline to 72 weeks | The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction. |
| Secondary | International Index of Erectile Function (IIEF)Scale Score. | Baseline to 72 weeks | The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction. |
| Secondary | Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | Baseline to 72 weeks. | The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 - 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Benign Prostate Hyperplasia (BPH) Impact Index Score | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | International Prostate Symptom Score Quality of Life (IPSS QOL) Score | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | American Urological Association(AUA) Nocturia Item | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Peak Uroflow | Baseline to 72 weeks | 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. | mL/sec | MEAN |
| SECONDARY | Post-void Residual | Baseline to 72 weeks | The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses. | mL | MEAN |
| SECONDARY | Prostate Specific Antigen (PSA) Level | Baseline to 72 weeks | 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. | ng/mL | MEAN |
| SECONDARY | International Index of Erectile Function (IIEF)Scale Score. | Baseline to 72 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | Baseline to 72 weeks. | 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. | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | Saw Palmetto | -2.20 | 95% Confidence Interval 5.83 | units on a scale | |
| Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | Placebo | -2.99 | 95% Confidence Interval 5.65 | units on a scale | |
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Saw Palmetto | Global Assessment: Change from Baseline | 49.9 | 95% Confidence Interval 26.9 | units on a scale |
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Placebo | Global Assessment: Change from Baseline | 50.58 | 95% Confidence Interval 28.7 | units on a scale |
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Saw Palmetto | Global Assessment: Satisfaction with Symptoms | 48.9 | 95% Confidence Interval 26.9 | units on a scale |
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Placebo | Global Assessment: Satisfaction with Symptoms | 50.6 | 95% Confidence Interval 28.8 | units on a scale |
| Benign Prostate Hyperplasia (BPH) Impact Index Score | Saw Palmetto | -0.81 | 95% Confidence Interval 2.38 | units on a scale | |
| Benign Prostate Hyperplasia (BPH) Impact Index Score | Placebo | -1.23 | 95% Confidence Interval 2.57 | units on a scale | |
| International Prostate Symptom Score Quality of Life (IPSS QOL) Score | Saw Palmetto | -0.34 | 95% Confidence Interval 1.26 | units on a scale | |
| International Prostate Symptom Score Quality of Life (IPSS QOL) Score | Placebo | -0.49 | 95% Confidence Interval 1.27 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saw Palmetto | 183 | |
| Overall Study | STARTED | Placebo | 186 | |
| Overall Study | COMPLETED | Saw Palmetto | 151 | |
| Overall Study | COMPLETED | Placebo | 155 | |
| Overall Study | NOT COMPLETED | Saw Palmetto | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 31 |
Source ClinicalTrials.gov
Adverse events266
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Saw Palmetto | 4 | 176 | 4 |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 181 | 3 |
| other | Cold | Respiratory, thoracic and mediastinal disorders | Saw Palmetto | 23 | 176 | 23 |
| other | Cold | Respiratory, thoracic and mediastinal disorders | Placebo | 19 | 181 | 19 |
| other | Frost bite to bronchial tubes | Respiratory, thoracic and mediastinal disorders | Saw Palmetto | 1 | 176 | 1 |
| other | Frost bite to bronchial tubes | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 181 | 0 |
| other | Increase mucus | Respiratory, thoracic and mediastinal disorders | Saw Palmetto | 1 | 176 | 1 |
| other | Increase mucus | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 181 | 0 |
| other | Strep Throat | Respiratory, thoracic and mediastinal disorders | Saw Palmetto | 1 | 176 | 1 |
| other | Strep Throat | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 181 | 1 |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saw Palmetto | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Saw Palmetto | 138 | 176 |
| Total, other adverse events | Placebo | 139 | 181 |
| Total, serious adverse events | Saw Palmetto | 18 | 176 |
| Total, serious adverse events | Placebo | 17 | 181 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DK063788 | Continuing Application for the Data Coordinating Center for (CAMUS) Trial (U01) | CANTOR, ALAN B. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2002 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Saw Palmetto vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00603304
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