Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00932022

Enrollment

127

Registered

2009-07-02

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Obesity, Overactive Bladder

Brief summary

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.

Interventions

DRUGTrospium Chloride, Extended Release (XR)

Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.

OTHERplacebo

Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence * Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit). * Obese

Exclusion criteria

* Chronic kidney failure * Abdominal bypass surgery for obesity * Moderate or severe memory impairment * Uncontrolled narrow angle glaucoma * Uncontrolled systemic disease * Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia

Design outcomes

Primary

Measure	Time frame	Description
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)	Baseline (Week 2), Week 14	Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.

Secondary

Measure	Time frame	Description
Percent Change From Baseline in Urgency Severity Associated With Toilet Voids	Baseline (Week 2), Week 14	Due to lack of evaluable data, analysis for this outcome measure was not performed.
Percent Change From Baseline in Voided Volume	Baseline (Week 2), Week 14	Due to lack of evaluable data, analysis for this outcome measure was not performed.
Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score	Baseline (Week 2), Week 14	Due to lack of evaluable data, analysis for this outcome measure was not performed.
Percent Change From Baseline in Percentage of Patients Continent	Baseline (Week 2), Week 14	Due to lack of evaluable data, analysis for this outcome measure was not performed.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Trospium Chloride XR 60 mg Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	64
Placebo Placebo capsule taken orally once daily for 14 weeks.	63
Total	127

Baseline characteristics

Characteristic	Trospium Chloride XR 60 mg	Placebo	Total
Age, Customized 18 to 75 years	64 Participants	63 Participants	127 Participants
Age, Customized <18 years	0 Participants	0 Participants	0 Participants
Age, Customized >75 years	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	64 Participants	63 Participants	127 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 64	3 / 63
serious Total, serious adverse events	0 / 64	1 / 63

Outcome results

Primary

Percent Change From Baseline in Urinary Urgency Incontinence (UUI)

Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.