General Information

Sanctura oral tablets contain trospium, an antimuscarinic antispasmodic agent. Antimuscarinic agents act as parasympathetolytics in muscular tissues, and has been shown to reduce the tonus (elastic tension) of smooth muscles of the bladder.

It is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Sanctura is administered via oral tablets of 20 mg twice daily, with a possible reduction in dosage, to 20 mg once daily, in the elderly and in subjects with renal impairment. Dosing should occur at least 1 hour prior to meal times.

Clinical Results

FDA approval of Sanctura was based upon two 12 week, double-blind, placebo controlled studies. The first study enrolled a total of 523 subjects with urge or mixed (predominantly urge) incontinence, with >70 micturitions and >7 urge incontinence episodes per week. Subjects received either 20 mg. Sanctura (n=262) or placebo (n=261) twice daily for 12 weeks. Subjects receiving Sanctura were shown to have significantly fewer micturitions per day (p < 0.001), significantly fewer urge incontinence episodes per week (p = 0.012), and significantly greater void volume per micturition (p < 0.001). The second trial, which enrolled 658 subjects (329 Sanctura, 329 placebo), consistently confirmed the results of the first.

Side Effects

Adverse events associated with the use of Sanctura may include, but are not limited to, the following:

Dry mouth

Constipation

Dyspepsia

Headache

In addition, angioneurotic edema was observed in one subject during clinical investigation; it is has not been determined if this reaction represents a clinically relevant event.

Mechanism of Action

Trospium chloride acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. It has been shown to have negligible affinity for nicotinic acteylcholine receptors at therapeutic doses, and to not easily cross the blood-brain barrier, yielding a localized, potent anticholinergic for peripheral targets. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

Literature References

Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, Auerbach S; Trospium Study Group. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. Journal of Urology. 2004 Jun;171(6 Pt 1):2311-5, quiz 2435.

Guay DR. Clinical pharmacokinetics of drugs used to treat urge incontinence. Clinical Pharmacokinetics. 2003;42(14):1243-85. Review.

Hay-Smith J, Herbison P, Ellis G, Moore K. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database of Systematic Reviews 2002;(3):CD003781. Review.