Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00746681

Enrollment

188

Registered

2008-09-04

Start date

2005-12-31

Completion date

2006-11-30

Last updated

2009-12-21

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

Conditions

Overactive Bladder

Brief summary

Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.

Interventions

DRUGTolterodine & Pregabalin

Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks

DRUGTolterodine

Tolterodine SR, Oral, 4 mg, once daily for 4 weeks

DRUGPlacebo

Placebo, Oral, twice daily for 4 weeks

DRUGPregabalin

Pregabalin, Oral, 150 mg twice daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women \> 18 years Old * Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week)

Exclusion criteria

* Subjects with symptoms of overactive bladder for less than 6 months prior to randomization. * Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test. * Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.

Design outcomes

Primary

Measure	Time frame
Change in mean voided volume per micturition (from baseline).	4 weeks

Secondary

Measure	Time frame
Percentage and absolute change in urgency episode frequency	4 Weeks
Mean severity of urgency episodes	4 Weeks
Percentage and absolute change in micturition frequency	4 Weeks
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).	4 Weeks
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)	4 Weeks
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)	4 Weeks
Patient Perception of Bladder Condition (PPBC) scale	4 Weeks
Percentage and absolute change in normalized micturition frequency (NMF)	4 Weeks

Countries

Czechia, Lithuania, Norway, Slovakia, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026