Phase 4
Completed N=322
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
Source: ClinicalTrials.gov NCT01089751 ↗Enrolled (actual)
322
Serious AEs
1.6%
Results posted
Sep 2013
Primary outcomePrimary: Percentage of Patients Continent (PPC) — 34.6; 17.1 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Continent (PPC) |
34.6; 17.1 | — |
| SECONDARY Change From Baseline in Continent Days Per Week (CDW) |
0.8; 1.0; 2.6; 1.3 | — |
| SECONDARY Change From Baseline in Nocturic Toilet Voids |
2.2; 2.3; -0.6; -0.3 | — |
| SECONDARY Change From Baseline in Urgency-Related Toilet Voids |
7.6; 7.5; -2.3; -1.6 | — |
| SECONDARY Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS) |
24.6; 23.7; -6.5; -3.4 | — |
| SECONDARY Change From Baseline in Voided Volume |
183.5; 187.4; 20.6; -8.0 | — |
| SECONDARY Change From Baseline in Urgency Severity |
1.4; 1.3; -0.4; -0.3 | — |
| SECONDARY Change From Baseline in Urgency Urinary Incontinence (UUI) |
2.9; 3.0; -1.1; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
- Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
- Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).
Exclusion Criteria
- Predominant stress or insensate incontinence
- History of neurogenic bladder
- Two urinary tract infections in the last six months
- Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
- Donated >500mL blood in the 30 days prior to the screening visit
Data sourced from ClinicalTrials.gov (NCT01089751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.