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

NCT00836381 | Completed Phase 4

• 1 other identifier: 2008-09-006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Antimuscarinics; Patient-reported goal achievement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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),

Study Arms (2)

Tolterodine ER

EXPERIMENTAL

Tolterodine ER 4mg once daily

Drug: Tolterodine extended-release (ER) 4mg

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

Tolterodine extended-release (ER) 4mg DRUG

Tolterodine extended-release (ER) 4mg once daily for 12 weeks

Also known as: Detrusitol ER 4mg

Tolterodine ER

Placebo DRUG

Identical Placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

KR (1)