Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00730535
First received: August 7, 2008
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.


Condition Intervention Phase
Overactive Bladder
Drug: Tolterodine
Drug: Tolterodine 6
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Risk factors and relapse rate of the OAB symptoms after drug discontinuation [ Time Frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Micturition diary efficacy parameters [ Time Frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation ] [ Designated as safety issue: No ]
  • Quality of life parameters: change in total score and subscale scores of OAB-questionnaire [ Time Frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation ] [ Designated as safety issue: No ]
  • Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment [ Time Frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolterodine 1 Drug: Tolterodine
Extended release tolterodine tartrate 4 mg, once daily, for 1 months
Other Name: Detrusitol ER 4mg
Experimental: Toterodine 3 Drug: Tolterodine
Extended release tolterodine tartrate 4 mg, once daily, for 3 months
Other Name: Detrusitol ER 4mg
Experimental: Tolterodine 6 Drug: Tolterodine 6
Extended release tolterodine tartrate 4 mg, once daily, for 6 months
Other Name: Detrusitol ER 4mg

Detailed Description:

Primary Objective:

  • To investigate the risk factors of OAB symptom relapse and retreatment in patients who showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

Secondary Objective:

  • To investigate the change of the patient perception and quality of life after antimuscarinic discontinuation
  • To find the rate of patients who have OAB symptom relapse.
  • To find the risk factors of patients who want retreatment.
  • To find the rate of patients who want retreatment.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female aged 18≤and ≤80 years
  2. Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) over 2 times per day
  3. Symptoms of urinary frequency (≥ 8 micturitions per 24 hours) as verified by baseline micturition diary.
  4. Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or frequency for ≥6 months.
  5. Ability and willingness to correctly complete the micturition diary and questionnaire
  6. 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. Clinical significant stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
  2. An average volume voided of > 200 ml per micturition as verified on the baseline micturition diary
  3. Total daily urine volume of > 3000 ml as verified on the baseline micturition diary
  4. Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine
  5. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  6. Symptomatic acute urinary tract infection (UTI) during the run-in period
  7. Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
  8. Diagnosed or suspected interstitial cystitis
  9. Uninvestigated hematuria or hematuria secondary to malignant disease.
  10. Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
  11. Patients with marked cystocele or other clinically significant pelvic prolapse.
  12. On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  13. Receipt of any electrostimulation or bladder training within the 14 days before the start of tolterodine SR, or expected to start such treatment during the study
  14. Use of any other drugs for the treatment of overactive bladder (e.g. anticholinergics except tolterodine) within the 14 days before the start of tolterodine SR, or expected to start such treatment during the study
  15. An indwelling catheter or practicing intermittent self-catheterization
  16. Use of any investigational drug within 2 months preceding the start of the study
  17. Patients with chronic constipation or history of severe constipation
  18. Pregnant or nursing women
  19. 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).
  20. Patients who have bladder cancer
  21. Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole).
  22. Any other condition which, in the opinion of the investigator, 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: NCT00730535

Locations
Korea, Republic of
Samsung Medical Center
50 Ilwon-Dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710
Holy Family Hospital, The Catholic University of Korea
Kyonggi-do, Korea, Republic of
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Pfizer
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00730535     History of Changes
Other Study ID Numbers: 2005-08-069
Study First Received: August 7, 2008
Last Updated: April 21, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Overactive bladder, Tolterodine,Symptoms Relapse, Predictor

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 23, 2014