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Sanctura XR (Trospium Chloride) - Summary



SANCTURA XR is an extended-release formulation of trospium chloride, a quaternary ammonium compound. Trospium chloride is an antispasmodic, antimuscarinic agent.

SANCTURA XR is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

See all Sanctura XR indications & dosage >>


Published Studies Related to Sanctura XR (Trospium)

Once-daily trospium chloride 60 mg extended release in subjects with overactive bladder syndrome who use multiple concomitant medications: Post hoc analysis of pooled data from two randomized, placebo-controlled trials. [2011.02.01]
BACKGROUND: Overactive bladder syndrome (OAB) is associated with various co-morbidities; treatment of these frequently results in multiple medication use (MMU) and the potential for drug-drug interactions, which may lead to adverse events and altered efficacy... The data support the conclusion that trospium chloride XR is safe and effective in patients with OAB taking multiple concomitant medications.

Trospium chloride once-daily extended release is efficacious and tolerated in elderly subjects (aged >/= 75 years) with overactive bladder syndrome. [2011.02]
CONCLUSIONS: * Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged >/= 75 years with OAB. * For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year. (c) 2010 THE AUTHORS. JOURNAL COMPILATION (c) 2010 BJU INTERNATIONAL.

Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder. [2011.01]
OBJECTIVES: This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB)... CONCLUSIONS: Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection. Copyright A(c) 2011 Elsevier Inc. All rights reserved.

Once-daily trospium chloride 60 mg extended-release provides effective, long-term relief of overactive bladder syndrome symptoms. [2011]
tolerability of trospium XR... CONCLUSIONS: Long-term treatment of OAB with once-daily trospium 60 mg XR is

Comparison of intravaginal electrical stimulation and trospium hydrochloride in women with overactive bladder syndrome: a randomized controlled study. [2010.04]
OBJECTIVE: To compare the effects of trospium hydrochloride and electrical stimulation on urodynamic parameters, bladder diary, quality of life and psychological symptoms in female patients with overactive bladder syndrome... CONCLUSION: No difference was detected between trospium hydrochloride and intravaginal electrical stimulation in the treatment of female overactive bladder syndrome. Discontinuation of both treatments caused deterioration in most of the objective and subjective symptoms of overactive bladder syndrome.

more studies >>

Clinical Trials Related to Sanctura XR (Trospium)

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial [Completed]
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.

Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily [Completed]
This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial [Completed]
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.

Trospium Chloride XR in Obese Female Patients With Overactive Bladder [Completed]
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

The Effect of Anticholinergics on Cognitive Function in the Elderly [Completed]
Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of

this medication is cognitive dysfunction. OAB is more prevalent in the elderly population -

a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women. Subjects will be randomized to: 1) trospium chloride or 2) placebo. There are three aims: 1) To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests. 2) To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management. 3) To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

more trials >>

Reports of Suspected Sanctura XR (Trospium) Side Effects

Constipation (13)DRY Mouth (9)Drug Ineffective (8)Urinary Retention (5)Vomiting (5)Headache (4)Nausea (4)Arthralgia (4)Diarrhoea (4)Flatulence (3)more >>


Based on a total of 1 ratings/reviews, Sanctura XR has an overall score of 10. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.

Sanctura XR review by 60 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   overactive bladder
Dosage & duration:   60mg taken 1 a day for the period of taken it for 4 months
Other conditions:   rapid pulse
Other drugs taken:   toperol
Reported Results
Benefits:   With OAB there was the urge to urinate frequently which felt like a constant mild bladder infection. There was some relief after a couple of days on this drug. However, some days I felt as poorly as I did without them. But after approximately 8 weeks almost all of the discomfort was gone. I feel pretty normal. One key to making this work is to deliberately not urinate too often. I have noticed that now I sometimes need to remind myself to go. I probably feel the urge less than I did before I had this problem.
Side effects:   Dry mouth if I fast from food. If I eat normally this does not happen. Other than that, no side effects.
Comments:   Take one capsule in the morning before eating breakfast - on an empty stomache.

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Page last updated: 2013-02-10

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