Urological Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01960517 -
Feasibility Assessment of ACS Catheter
|
Phase 2/Phase 3 |