Nutrition Business Journal

BioLogic Founders Describe Evolution of Urinary Health Ingredient

In March 2005, BioLogic Health Solutions Ltd. of Australia launched UroLogic in the U.S., the company's branded supplement for urinary incontinence associated with aging and childbirth as well as overactive bladder. NBJ talks to Tracey Seipel, a naturopath, clinical nutritionist, herbalist and co-founder of BioLogic, to learn how this condition-specific supplement came to market.

NBJ: What was the evolution of UroLogic?

TS: We started with the category. We saw that urinary incontinence and overactive bladder affected up to 16% of people and greatly impacted their quality of life, yet was largely unaddressed. We knew from clinical experience the importance of bladder health and the benefit of certain herbs in maintaining healthy, strong bladder tone. Several clinical studies have highlighted certain herbs in particular. We started with this information and, over the next six years, focused on refining specific extracts and combinations of herbs and minerals to develop what we now believe is the best natural formula for urinary incontinence associated with aging and childbirth.

NBJ: What are the main ingredients?

UroLogic contains Horsetail (Equisetum arvense), traditionally used to address symptoms of incontinence, and the Ayurvedic herb Crateva nurvala, which assists with bladder tone, combined with minerals to support nerve transmission.

NBJ: What are the primary studies behind the product?

TS: There is one published clinical trial on Crataeva and Equisetum to reduce symptoms of urinary incontinence (Steels, E. et al. Australian Continence Journal, August 2002). Unpublished work on UroLogic includes a pilot trial that indicated efficacy in reducing symptoms of urinary incontinence, including frequency, nocturia, urgency and bladder discomfort. Symptom relief occurred after four weeks of treatment, with the severity of symptoms reducing further, especially in the 4- to 8-week period. A randomized double-blind placebo controlled study with 73 participants has just been completed in the U.S. Results were very positive. Studies have also shown UroLogic is not mutagenic, has high ORAC (antioxidant) value and is not expected to adversely interact with drugs. We find that 80% of product users experience a benefit from UroLogic. This ranges from a reduction in daytime frequency or getting out of bed at night to dramatic reduction in the use of incontinence pads/adult protection. In some cases UroLogic can help to totally eliminate any need for pad protection.

NBJ: Is education needed to manage consumer expectations?

TS: Yes, consumers should be aware of the timeframes for results. UroLogic helps to tone and strengthen the bladder and surrounding tissues; it does not stop urine production or flow but promotes proper urine flow. So the tonic effect builds up over a period of weeks to months. Fifty percent of people should experience some effect by three to four weeks, with 80% of people experiencing best results at two to three months.

NBJ: What are the prescription drug treatments for urinary incontinence?

TS: The two most common drugs are Oxybutynin and Tolterodine—both anti-cholinergic muscarinic receptor antagonists. Recent studies suggest that Oxybutynin reduces incontinence by 9%-56% with up to a 44% cure rate. Tolterodine reduces incontinence by 50% and decreases the number of micturitions in a 24-hour period by 21%. Dry mouth is a common side effect for both Oxybutynin and Tolterodine. Other side effects can include blurred vision, nausea, abdominal discomfort, headaches or memory loss. By contrast, a very small number of UroLogic users may occasionally experience digestive discomfort, and we had three reported cases of constipation in our trials. Our market research shows that people are not prepared to tolerate the sometimes severe side effects [of drugs] and are very willing to use a natural product for proper bladder tone and symptoms of urinary incontinence associated with aging and childbirth.

NBJ: How do the costs compare?

TS: Our research shows that it costs about $94 for 30 days use of incontinence pads (based on average use of four medium absorbency pads per day and one heavy absorbency pad per night) plus $1 per week for laundry costs, undergarments and odor masking sprays. Taking oral Oxybutinin at 5-30mg per day for 30 days costs between $94 and $224. Taking oral Tolterodine at 2-4mg per day for 30 days costs $93 to $107. For UroLogic in the U.S. , cost for 30 days usage is $39.95 to $69.95.

NBJ: How long has UroLogic been on the market?

TS: BioLogic has been distributing its full product range in Australian since 1999, and exports to Taiwan and Hong Kong. Our products were launched in the U.S. at Natural Products Expo West, Anaheim in 2005, and the first U.S. sales were made in August 2005. UroLogic is a trademarked ingredient which will be sold by U.S. distributors. Product is available by mail order and in some health food stores. We expect UroLogic to be widely available throughout the U.S. by June 2006.

NBJ: What will be your marketing strategy for the U.S.?

TS: We intend to market UroLogic across all available channels, including doctors. Our strategy is to partner with reputable, experienced distributors to ensure that UroLogic is widely available to the consumers who need it most. Marketing will be a combination of our own PR and mainstream advertising, as well as our distributors’ marketing efforts.

NBJ: How much have you invested in researching urinary health?

TS: We have been actively researching urinary health since January 2000, and for the past six years we have dedicated a significant portion of our R&D budget to funding research which incorporates safety, drug interactions, efficacy and other potential applications (e.g., antioxidant effects). We have also undertaken significant market research (including surveys, focus groups, etc.) in Australia, the U.S. and more recently the U.K., so that we can fully appreciate how urinary problems affect people’s lives to ensure that we can directly address their needs and concerns.

NBJ: Does the Australian regulatory environment encourage a natural OTC alternative like Urologic?

TS: The Australian regulatory environment allows companies to develop and sell innovative natural products for a wide variety of health concerns, as long as there is sufficient evidence to support product safety and efficacy. The Australian government’s trade commission, Austrade, has been very supportive in helping us develop new export markets. The Queensland State government (our home state) provided funding for a double blind placebo- controlled trial of UroLogic conducted by the Health Research and Studies Center, Sphera Foundation, Los Altos, Calif.

NBJ: For which conditions do you believe supplements can offer the best alternatives to OTC or prescription drugs?

TS: Chronic conditions that significantly affect quality of life, arthritis, fertility, reproductive health, cardiovascular health, brain function and age-related conditions in general. Urinary incontinence is often a natural part of life and the aging process, not a disease as such that may need harsh intervention. Natural products are therefore ideal in supporting this natural bodily function. Success in conditionspecific categories largely relates to education and those conditions that have been actively promoted over many years. As the public becomes more informed about health and has easier access to information, people will become armed with the knowledge to help them use more and more herbs and nutritionals for their health. It is now up to dietary supplement companies to develop well-researched, safe and efficacious products that address specific consumer needs. Consumers will then have the confidence to address their health concerns with natural products.

BioLogic Health Solutions Ltd. (Brisbane, Australia) is a privately owned company. Two of the founding shareholders, sisters Debra and Tracey Seipel, also manage and direct the company.