Health Innovation Research

NEW STUDY ANNOUNCEMENT

Overactive Bladder Study

Are you currently experiencing symptoms of Overactive Bladder, such as needing to go to the toilet urgently or frequently, or light bladder leakage?

If so, you could help assess a new herbal product aimed at improving symptoms of Overactive Bladder…and participate from the comfort of your home.

Check your eligibility here

Thank you for your interest in RDC Clinical’s new study which is evaluating the effectiveness of a herbal formula on symptoms of Overactive Bladder. Overactive Bladder is a bladder control condition comprising of a group of urinary symptoms such as:

  • Urgency (a sudden urge to urinate)
  • frequency (urinating more than 8 times in a 24 hour period), and
  • leakage (incontinence).

The most common symptom is the sudden urge to urinate, which can be difficult to control. Some people may leak urine when they feel this urge. Another symptom is the need to pass urine frequently during the day, and for some people overnight, causing interrupted sleep.

We’re looking for healthy adults aged over 18 years who are currently experiencing symptoms of Overactive Bladder. This study is being conducted remotely, which means that there are no face-to-face visits required – participation can be completed from your home.

How long is the study, and when does it start?

Recruitment is now open for this study. Your participation in this study will last for 12 weeks. Whilst in the study, you’ll be asked to complete some online questionnaires and diaries to collect information about your Overactive Bladder symptoms. This will occur at 5 time-points over the 12 weeks.

You will be sent study product in the form of capsules to take each day for the duration of the study.

If you’re interested in taking part, we’d love your help. Please see below for more information. The eligibility and registration form is at the bottom of the page.

About the product you’ll help test…

The study product is a combination formula, consisting of 4 herbal ingredients: Crateva, Lindera, Alpinia and Passiflora. These ingredients have been traditionally used in Ayurvedic, Chinese and Western herbal medicine for bladder health and are thought to help relieve symptoms of bladder weakness and improve bladder control.

The herbal formula will be taken as 2 x 450 mg capsules per day (total daily dose 900mg).

As this study is placebo controlled, you may or may not be allocated the active product. 50% of participants will be assigned a placebo, microcrystalline cellulose (a harmless inactive substance typically used as an additive in food production). During the study period, neither you or the study investigators will know which product you have been allocated.

Why is this study being conducted?
Overactive Bladder (OAB) affects between 8% and 13.9% of the population, with prevalence increasing with age, increased BMI, post-menopause or post-vaginal childbirth. OAB symptoms have a negative impact on quality of life, especially when sleep is interrupted.

Management of OAB symptoms includes lifestyle modification, use of incontinence products such as pads and in some cases prescription pharmaceuticals. However, alternative herbal therapies are becoming an increasingly popular treatment option.

This study will assess the effectiveness of a specific combination of herbs on improving symptoms of OAB.

What is required of participants?

This study is a remote study which means that you can participate from home – no in-clinic visits are required. Study data is collected via online questionnaires and diaries, so internet access is required.

The study will involve approximately 120 adults. Each participant will be sent study product (provided as capsules) to take for the 12-week study period. During this time, you will be asked to complete some online questionnaires and diaries at 5 time-points to gather information about your Overactive Bladder symptoms.

The timepoints are:

  • Baseline (beginning of study)
  • Week 2
  • Week 4
  • Week 8
  • Week 12 (end of study)

The information we collect during the study will enable the investigators to assess the product’s effectiveness on symptoms of Overactive Bladder over the 12 week study period.

Payment

You will be eligible for a $100 reimbursement to cover your time and any out of pocket expenses. The payment will be made via direct deposit to your nominated bank account once all study requirements (12 weeks) participation) have been met.

If you’re an otherwise healthy adult and 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.

Check if you can take part… study participant requirements.
  • Aged over 18
  • Experiencing symptoms of Overactive Bladder
  • Generally healthy with no uncontrolled serious illness
  • Non-smoker
  • Agree not to use other supplements or prescribed medications for Overactive Bladder for the duration of the trial, and within 2 weeks prior to commencing the study
  • Agree not to use any diuretics for the duration of the study, and within 4 weeks prior to commencing the study
  • Not currently undertaking regular pelvic floor exercises
  • Able to commit to taking the study product daily for 12 weeks and have an internet enabled device for completing online questionnaires.
  • Females: NOT currently trying to conceive, pregnant or breastfeeding.

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.

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: 2020-12-1256. Trained Trial Co-ordinators 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.