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

NCT00836381

Last updated date
Study Location
Samsung Medical Center
Seoul, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Female aged ≥ 18 and ≤ 80 years

2. 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

3. Symptoms of OAB for ≥ 3 months.

4. Ability and willingness to correctly complete the micturition diary and questionnaire

5. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Subjects with stress incontinence or mixed stress/urge incontinence where stress
incontinence is the predominant component based on prior history.


2. 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.


3. Any condition that is a contraindication for anticholinergic treatment, including
uncontrolled narrow-angled glaucoma, urinary retention or gastric retention


4. Symptomatic acute urinary tract infection (UTI) during the run-in period


5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last
year


6. Diagnosed or suspected interstitial cystitis


7. Clinically significant bladder outlet obstruction or poor detrusor function defined by
clinical symptoms and investigator's opinion according to local standard of care


8. Previous history of major urethral and/or bladder surgery


9. History of radiation treatment (external or interstitial) to pelvic organs or external
genitalia for any reason.


10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply


11. Patients with marked cystocele or other clinically significant pelvic prolapse.


12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including
bladder, uterine or cervical cancer


13. 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


14. On an unstable dosage of any drug with anticholinergic side effects, or expected to
start such treatment during the study


15. 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


16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not
been on a stable dose for at least three months


17. Receipt of any electrostimulation or bladder training within the 14 days before
randomization, or expected to start such treatment during the study


18. An indwelling catheter or practicing intermittent self-catheterization


19. Use of any investigational drug within 1 months preceding the start of the study


20. Patients with chronic constipation or history of severe constipation


21. Pregnant or nursing women


22. 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).


23. Any other condition which makes the patient unsuitable for inclusion.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder
Official Title  ICMJE Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase ?)
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.

Detailed Description
  1. 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.
  2. 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.

  3. 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Tolterodine extended-release (ER) 4mg
    Tolterodine extended-release (ER) 4mg once daily for 12 weeks
    Other Name: Detrusitol ER 4mg
  • Drug: Placebo
    Identical Placebo once daily
Study Arms  ICMJE
  • Experimental: Tolterodine ER
    Tolterodine ER 4mg once daily
    Intervention: Drug: Tolterodine extended-release (ER) 4mg
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
56
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2009)
74
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female aged ? 18 and ? 80 years
  2. 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

  3. Symptoms of OAB for ? 3 months.
  4. Ability and willingness to correctly complete the micturition diary and questionnaire
  5. 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:

  1. Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
  2. 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.
  3. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  4. Symptomatic acute urinary tract infection (UTI) during the run-in period
  5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
  6. Diagnosed or suspected interstitial cystitis
  7. Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
  8. Previous history of major urethral and/or bladder surgery
  9. History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
  10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply
  11. Patients with marked cystocele or other clinically significant pelvic prolapse.
  12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
  13. 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
  14. On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  15. 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
  16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
  17. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
  18. An indwelling catheter or practicing intermittent self-catheterization
  19. Use of any investigational drug within 1 months preceding the start of the study
  20. Patients with chronic constipation or history of severe constipation
  21. Pregnant or nursing women
  22. 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).
  23. Any other condition which makes the patient unsuitable for inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00836381
Other Study ID Numbers  ICMJE 2008-09-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KYU-SUNG LEE, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kyu-Sung Lee, Ph.DSamsung Medical Center
PRS Account Samsung Medical Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP