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Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01089751
First received: March 17, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: trospium chloride
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients Continent (PPC) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.


Secondary Outcome Measures:
  • Change From Baseline in Continent Days Per Week (CDW) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.

  • Change From Baseline in Nocturic Toilet Voids [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    A nocturic (nighttime) toilet void is identified if the patient marks "Yes" for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.

  • Change From Baseline in Urgency-Related Toilet Voids [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    Urgency-related toilet void (or urinary urgency) is identified if the patient marks "Yes" for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.

  • Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement.

  • Change From Baseline in Voided Volume [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.

  • Change From Baseline in Urgency Severity [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.

  • Change From Baseline in Urgency Urinary Incontinence (UUI) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
    Urgency urinary incontinence is identified if the patient marks "Yes" for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.


Enrollment: 322
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sanctura XR®
Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
Drug: trospium chloride
Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks
Other Name: Sanctura XR®
Placebo Comparator: Placebo
Placebo once daily on an empty stomach for 14 weeks.
Drug: placebo
Placebo once daily on an empty stomach for 14 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089751

Locations
United States, California
La Mesa, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01089751     History of Changes
Other Study ID Numbers: GMA-SXR-09-004
Study First Received: March 17, 2010
Results First Received: June 12, 2013
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Trospium chloride
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 25, 2014