NEW STUDY ANNOUNCEMENT
New Potential Treatment for LOWER URINARY TRACT SYMPTOMS (LUTS) IN MEN
Seeking males aged 45-80 who EXPERIENCE SYMPTOMS SUCH AS INCREASED FREQUENCY OR URINATION, INTERMITTENCY OF URINE STREAM, URGENCY OF URINATION OR WEAK STREAM to help assess a potential new treatment product.
Thank you for your interest in our LUTS study which is investigating the effectiveness of a new product as a potential treatment. We are looking for healthy males, aged 45-80 experiencing LUTS.
Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.
Why is this study being conducted?
Lower Urinary Tract Symptoms (LUTS) is a highly prevalent condition common in the male population that can negatively impact quality of life.
Lower urinary tract symptoms include:
- nocturia (getting up to urinate at night)
- urinary frequency
- urinary urgency
- weak or interrupted urinary stream.
Current treatments include medical and surgical options, which may not be feasible for some sufferers. Therefore, more natural options are being developed and studied.
This study will involve healthy males, aged 45-80 years experiencing LUTS.
How long is the study, and when does it start?
Your involvement in the study will be 12 weeks, during this time you will be able to complete most of the assessments from home, but you will be asked to visit a clinic to provide a blood sample at the beginning and end of the study.
To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible.
Please see below for more information. You can find the eligibility and registration form at the bottom of this page.
About the product you’ll help investigate…
For this study, we are assessing the effectiveness of a saw palmetto capsule treatment product compared to a different saw palmetto product and compared to a placebo.
Saw palmetto (Serenoa repens) is a small, low growing, dwarf palm tree native to the West Indies and south-eastern America, with the medicinal part being the ripe fruit or ‘berry’. Since the 1800s, Saw palmetto has been used as a treatment for testicular atrophy, erectile dysfunction, and prostate swelling and inflammation. It is currently the most widely used phytotherapeutic treatment for BPH and contains fatty acids and plant sterols which are thought to contribute to its anti-androgenic (hormone blocking) and anti-inflammatory effects.
The product for this study is in capsule form, and participants will be asked to take 2 capsules daily for 12 weeks.
As this study is placebo-controlled, you will be randomly allocated to either one of the two active products or the placebo product on a chance basis, this means you will have a 2 out of 3 chance of receiving active product. During the study period, neither you nor the study investigators will know the product you have been allocated. However, if it is necessary for your health, we are able to discover which product you have been allocated.
What is required of participants?
Your involvement in the study will be for 12 weeks. Most of the study requirements can be completed at home (such as completing online questionnaires and recording urinary frequency); however, you will be required to attend two in-clinic visits to provide a blood sample at the beginning and end of the study.
You will also be asked to take your allocated study product daily for the 12 week study duration.
The information we collect during the study will enable the investigators to assess the product’s effectiveness on symptoms of LUTS.
Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.
Payment
You will be eligible for a $200 reimbursement of your time. The payment will be made via direct deposit to your nominated bank account once all study requirements have been met.
If you would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.
Study LocationS
This study is accepting participants from Brisbane and at various other locations around Australia.
Brisbane: You can participate in this study if you are located in Brisbane by attending our RDC Clinic in Spring Hill. We offer free undercover parking directly next door under the Kennigo Hotel, 22 Kennigo Street, Spring Hill.
Getting to Us
- Private Transport: free undercover parking available at Kennigo Hotel Car Park as well as metered street parking (availability for street parking is day/time dependent). Please enter 22 Kennigo Street, Spring Hill into your GPS.
- Train: Fortitude Valley Train Station (350m away)
- Bus: multiple bus stops within close proximity
Other locations around Australia: You can participate in this study if you are able to attend an ACL pathology clinic close to you. Please refer to the following website to check for an ACL clinic in your area.
Check if you can take part… study participant requirements.
- Male aged 45-80 years
- Generally healthy with no uncontrolled serious illnesses
- Experiencing Lower Urinary Tract Symptoms (LUTS)
- Not currently taking prescription medication for BPH or LUTS
- Able to provide informed consent
- Able to commit to completing the study requirements
- Able to attend either the RDC Brisbane Clinic or an ACL Clinic for blood collection
Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.
Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.
Ethics approval & privacy… you’ll be in safe, professional hands.
This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2023-06-0669. The study is also registered on the clinicaltrials.gov under Registration Number: NCT-6266000.
Trained trial coordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.