UrologicalPhase 3CAMUSNCT00603304
Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
A Phase 3 study testing Saw Palmetto - first 24 weeks, Saw Palmetto - weeks 24 - 48 and Saw Palmetto - weeks 48 - 72 in people with Urological, run by University of Alabama at Birmingham at 11 sites in 2 countries.
Trial summary
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urological
- What is being tested?
- Saw Palmetto - first 24 weeks, Saw Palmetto - weeks 24 - 48 and Saw Palmetto - weeks 48 - 72
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Feb 2008to Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the study, potential participants must meet all of the following eligibility criteria:
- Male at least 45 years of age.
- Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
- AUA symptom score ≥ 8 and ≤ 24 at both screening visits.
- Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Who cannot join
- Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial:
- Any prior invasive intervention for BPH.
- Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
- Alpha blocker within one month.
- Reported allergic reaction to Serenoa repens.
- Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma.
Show all 24Show fewer
- Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months.
- Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl).
- Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement.
- Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement.
- Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome.
- Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit.
- Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score >14 at screening.
- Unstable medical condition within the past 3 months.
- History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction.
- Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery.
- Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
- Documented bacterial prostatitis within the past year.
- Two documented independent urinary tract infections of any type in the past year.
- Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin.
- Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not.
- Unable to follow protocol directions due to organic brain or psychiatric disease.
- History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
- Any serious medical condition likely to impede successful completion of the study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
University of Colorado
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Northwestern University
Chicago, Illinois, 60611
University of Texas - Southwestern Medical Center
Dallas, Texas, 21201
University of Iowa
Iowa City, Iowa, 52242
Yale University
New Haven, Connecticut, 06519
New York University
New York, New York, 10006
Cornell University
New York, New York, 10021
Kaiser Permanente Division of Research
Oakland, California, 94612
Washington University
St Louis, Missouri, 63110
About this study
Official title: Complementary and Alternative Medicine for Urological Symptoms (CAMUS)
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills.
This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.
Read the detailed description
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).
BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.
A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
- Conditions
- Urological
- Being tested
- Saw Palmetto - first 24 weeks, Placebo - first 24 weeks, Saw Palmetto - weeks 24 - 48, Placebo - weeks 24 - 48, Saw Palmetto - weeks 48 - 72
- Keywords
- Serenoa repens, Urological symptoms, hyperplasia, BPH
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saw Palmetto - first 24 weeksDrug
Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - first 24 weeksDrug
Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Saw Palmetto - weeks 24 - 48Drug
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - weeks 24 - 48Drug
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Saw Palmetto - weeks 48 - 72Drug
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - weeks 48 - 72Drug
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). Receives: Drug: Placebo - first 24 weeks; Drug: Placebo - weeks 24 - 48; Drug: Placebo - weeks 48 - 72 |
| Saw Palmetto | Active comparator | Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). Receives: Drug: Saw Palmetto - first 24 weeks; Drug: Saw Palmetto - weeks 24 - 48; Drug: Saw Palmetto - weeks 48 - 72 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.
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.
Measured: Baseline to 72 weeks
Secondary outcomes (14)
Participants Global Assessments of Improvement and Satisfaction at End of Study.
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.
Measured: Baseline to 72 weeks
Benign Prostate Hyperplasia (BPH) Impact Index Score
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.
Measured: Baseline to 72 weeks
International Prostate Symptom Score Quality of Life (IPSS QOL) Score
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.
Measured: Baseline to 72 weeks
American Urological Association(AUA) Nocturia Item
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.
Measured: Baseline to 72 weeks
Peak Uroflow
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.
Measured: Baseline to 72 weeks
Post-void Residual
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.
Measured: Baseline to 72 weeks
Prostate Specific Antigen (PSA) Level
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.
Measured: Baseline to 72 weeks
International Index of Erectile Function (IIEF)Scale Score.
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.
Measured: Baseline to 72 weeks
Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
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.
Measured: Baseline to 72 weeks.
International Continence Society Male Incontinence Symptom (ICSmale IS) Score
The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.
Measured: Baseline to 72 weeks
Jenkins Sleep Scale Score
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.
Measured: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 - 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 - 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.
Measured: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 - 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.
Measured: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 - 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (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 12, which represents the highest level of dysfunction.
Measured: Baseline to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UrologicalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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
- Responsible party
- Principal investigator, Alan Cantor, PhD, University of Alabama at Birmingham
- Investigators
- Michael Barry, MD, Study chair, Massachusetts General HospitalAlan Cantor, PhD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603304
- Sponsor's protocol ID
- X021004002
- Other IDs
- U01DK063788, Tracking # (UAB) 000175609
- Acronym
- CAMUS
- Status last verified
- Sep 2012
- First submitted
- 20 Dec 2007
- Last updated
- 12 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
PubMed 20007408Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9.
PubMed 21554128Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8.
PubMed 21741692Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17.
PubMed 21497839Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364.
PubMed 21954478Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22.
PubMed 23083656
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine for Urological Symptoms (CAMUS)
- ClinicalTrials.gov ID
- NCT00603304
- Acronym / sponsor ID
- CAMUS / X021004002
- Conditions
- Urological
- Keywords
- Serenoa repens, Urological symptoms, hyperplasia, BPH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills.
This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.
Detailed description
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).
BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.
A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo - first 24 weeks, Drug: Placebo - weeks 24 - 48, Drug: Placebo - weeks 48 - 72Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). |
| Saw Palmetto | Active comparator | Drug: Saw Palmetto - first 24 weeks, Drug: Saw Palmetto - weeks 24 - 48, Drug: Saw Palmetto - weeks 48 - 72Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be eligible for the study, potential participants must meet all of the following eligibility criteria:
- Male at least 45 years of age.
- Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
- AUA symptom score ≥ 8 and ≤ 24 at both screening visits.
- Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Key exclusion criteria (24 listed)
- Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial:
- Any prior invasive intervention for BPH.
- Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
- Alpha blocker within one month.
- Reported allergic reaction to Serenoa repens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saw Palmetto - first 24 weeksParticipants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. | Drug | Saw Palmetto |
| Placebo - first 24 weeksParticipants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. | Drug | Placebo |
| Saw Palmetto - weeks 24 - 48Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. | Drug | Saw Palmetto |
| Placebo - weeks 24 - 48Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks. | Drug | Placebo |
| Saw Palmetto - weeks 48 - 72Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. | Drug | Saw Palmetto |
| Placebo - weeks 48 - 72Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. | Drug | Placebo |
Primary outcome
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
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.
14 secondary outcomes
Participants Global Assessments of Improvement and Satisfaction at End of Study.
Time frame: Baseline to 72 weeks
Benign Prostate Hyperplasia (BPH) Impact Index Score
Time frame: Baseline to 72 weeks
International Prostate Symptom Score Quality of Life (IPSS QOL) Score
Time frame: Baseline to 72 weeks
American Urological Association(AUA) Nocturia Item
Time frame: Baseline to 72 weeks
Peak Uroflow
Time frame: Baseline to 72 weeks
Post-void Residual
Time frame: Baseline to 72 weeks
Prostate Specific Antigen (PSA) Level
Time frame: Baseline to 72 weeks
International Index of Erectile Function (IIEF)Scale Score.
Time frame: Baseline to 72 weeks
Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
Time frame: Baseline to 72 weeks.
International Continence Society Male Incontinence Symptom (ICSmale IS) Score
Time frame: Baseline to 72 weeks
Jenkins Sleep Scale Score
Time frame: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
Time frame: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
Time frame: Baseline to 72 weeks
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
Time frame: Baseline to 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20007408Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
- Background: PubMed 21554128Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9.
- Results publication: PubMed 21741692Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8.
- Results publication: PubMed 21497839Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17.
- Results publication: PubMed 21954478Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364.
- Derived from this study: PubMed 23083656Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22.
Related trials for Urological
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Enrolling by invitationObservational study
An Observational Post-Authorization Safety and Effectiveness Study of Ravulizumab in Adult Patients Aged 18 and Older Diagnosed With Paroxysmal Nocturnal Hemoglobinuria Using Multicenter Electronic Medical Records in South Korea
Hemoglobinuria, Paroxysmal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Barry, MD study chair
Massachusetts General Hospital
Alan Cantor, PhD principal investigator
The University of Alabama at Birmingham
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saw Palmetto - first 24 weeks, Saw Palmetto - weeks 24 - 48 and Saw Palmetto - weeks 48 - 72 in people with Urological, run by University of Alabama at Birmingham at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603304, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.