Status:
COMPLETED
Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
Lead Sponsor:
KYU-SUNG LEE
Collaborating Sponsors:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
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 Tolte...
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...
Eligibility Criteria
Inclusion
- Female aged 18≤and ≤80 years
- Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) over 2 times per day
- Symptoms of urinary frequency (≥ 8 micturitions per 24 hours) as verified by baseline micturition diary.
- Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or frequency for ≥6 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
- Clinical significant stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
- An average volume voided of \> 200 ml per micturition as verified on the baseline micturition diary
- Total daily urine volume of \> 3000 ml as verified on the baseline micturition diary
- 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
- 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 UTIs defined as having been treated for symptomatic UTIs \> 4 times in the last year
- Diagnosed or suspected interstitial cystitis
- Uninvestigated hematuria or hematuria secondary to malignant disease.
- Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
- Patients with marked cystocele or other clinically significant pelvic prolapse.
- On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
- 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
- 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
- An indwelling catheter or practicing intermittent self-catheterization
- Use of any investigational drug within 2 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).
- Patients who have bladder cancer
- Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole).
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00730535
Start Date
August 1 2006
End Date
July 1 2009
Last Update
December 2 2019
Active Locations (4)
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1
Samsung Medical Center
Irwon-dong, Seoul, South Korea, 135-710
2
Holy Family Hospital, The Catholic University of Korea
Gyeonggi-do, South Korea
3
Asan Medical Center, Ulsan College of Medicine
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea