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

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: Tolterodine extended-release (ER) 4mg Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by KYU-SUNG LEE, Samsung Medical Center:

Primary Outcome Measures:

Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4 [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) ]

Secondary Outcome Measures:

Assessment of patient-reported treatment goal [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) ]
Patient-reported outcomes [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ]
Micturition diary efficacy parameters [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ]
Safety parameters [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ]


Enrollment:	56
Study Start Date:	February 2009
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tolterodine ER Tolterodine ER 4mg once daily	Drug: Tolterodine extended-release (ER) 4mg Tolterodine extended-release (ER) 4mg once daily for 12 weeks Other Name: Detrusitol ER 4mg
Placebo Comparator: Placebo Placebo once daily	Drug: Placebo Identical Placebo once daily

Detailed Description:

Objectives
1. 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.
2. 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
1. 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
2. Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
3. 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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

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: NCT00836381

Locations


Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Pfizer

Investigators


Principal Investigator:	Kyu-Sung Lee, Ph.D	Samsung Medical Center

More Information


Responsible Party:	KYU-SUNG LEE, Proffesor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00836381 History of Changes
Other Study ID Numbers:	2008-09-006
Study First Received:	February 2, 2009
Last Updated:	May 29, 2013

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:


Overactive bladder Antimuscarinics Patient-reported goal achievement

Additional relevant MeSH terms:


Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Tolterodine Tartrate	Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents

ClinicalTrials.gov processed this record on June 23, 2017