Though not life-threatening, Overactive Bladder (OAB) is a debilitating and stigmatizing disorder that affects nearly 30 million Americans. OAB occurs when bladder muscles contract regardless of urine volume, resutling in the urgent need to void.

The urinary bladder performs two functions: storage and voiding. During the storage phase, muscles in the bladder and urinary tract are relaxed. When it reaches capacity, the bladder sends nerve signal to the brain that trigger the urge to void. Urination occurs when the muscles in the pelvis and urethra relax, and the detrusor contracts.

Traditional OAB therapies include oral medications—antimuscarinics such as oxybutynin chloride and tolterodine—which provide relief for some patients by relaxing the detrusor. But because these drugs often cause systemic side-effects; many patients simply can’t tolerate them.Similarly, sacral nerve stimulation, while sometimes effective, can cause pain and infection at the implant site. Patients who can’t tolerate or don’t respond to such therapies have what is called refractory OAB. Since 2013, botulinum toxin (Botox) injected directly into the bladder wall has proven effective for some refractory OAB patients. But this invasive process is often painful and carries a significant risk of infection.

LP-09 is a liposomal formulation of botulinum toxin that has proved safe and effective the treatment of refractory OAB. In clinical trials, LP-09 has shown a reduction in urinary frequency and urinary urgency with no adverse events such as urinary retention, incontinence, or urinary tract infection. LP-09 requires no cytoscopic procedure or needle injections to the bladder, only a simple instillation that can be performed by nursing staff in a doctors office. This relatively non-invasive procedure is covered by existing CPT codes.

These charts summarize a two-center, 60-patient clinical trial conducted in Taiwan. They show a marked reduction in micturition (urination) and urinary urgency. Here, LP-09 is indicated as Lipo-BoNT. Saline was used as the placebo control. For more information on this study, visit the Publications and Clinical Trials pages.