Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

Study Overview
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Brief Summary
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For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA). Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit. This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.

Detailed Description
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Objectives Primary objective: To explore the Patient-reported Goal Attainment (PGA) after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients. Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients. Specific aim : To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients. Experimental/research design 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks. Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks

Official Title
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Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Tolterodine extended-release (ER) 4mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged ≥ 18 and ≤ 80 years Symptoms of OAB as verified by the screening 3 day micturition diary, defined by: Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours Symptoms of OAB for ≥ 3 months. Ability and willingness to correctly complete the micturition diary and questionnaire Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits Exclusion Criteria: Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history. Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention Symptomatic acute urinary tract infection (UTI) during the run-in period Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year Diagnosed or suspected interstitial cystitis Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care Previous history of major urethral and/or bladder surgery History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason. Subjects with neuropathology that could affect the lower urinary tract or nerve supply Patients with marked cystocele or other clinically significant pelvic prolapse. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study An indwelling catheter or practicing intermittent self-catheterization Use of any investigational drug within 1 months preceding the start of the study Patients with chronic constipation or history of severe constipation Pregnant or nursing women Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy). Any other condition which makes the patient unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolterodine ER<br>Tolterodine ER 4mg once daily | Drug: Tolterodine extended-release (ER) 4mg<br>* Tolterodine extended-release (ER) 4mg once daily for 12 weeks<br>* Other names: Detrusitol ER 4mg;|
| Placebo Comparator: Placebo<br>Placebo once daily | Drug: Placebo<br>* Identical Placebo once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4 |  | visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient-reported treatment goal |  | visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) | 
| Patient-reported outcomes |  | visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), | 
| Micturition diary efficacy parameters |  | visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), | 
| Safety parameters |  | visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Antimuscarinics, Patient-reported goal achievement