Status:
COMPLETED
Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients
Lead Sponsor:
Samsung Medical Center
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
The urologic literature suggests that there is an association between a variety of psychiatric disorders and incontinence. Most notably, depression is found in a significant percentage of patients wit...
Detailed Description
* 3-month, prospective, open-label, comparative trial * Primary Objectives: * To investigate the changes of OAB symptoms in patients who did not showed therapeutic benefits after 3 months of treatm...
Eligibility Criteria
Inclusion
- Female aged ≥ 18 and ≤80 years
- On a stable dose of an antimuscarinic agents for at least 3 months
- Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by:
- Mean urinary frequency ≥8 times/24 hours
- Mean number of urgency episodes, with/without urgency incontinence, ≥1 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 in the micturition diary)
- A rating of the bladder condition at Baseline prior to randomization as "Some Moderate Problems", "Severe Problems", or "Many Severe Problems" on the Patient Perception of Bladder Condition (PPBC) questionnaire
- 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
- Patients who have past psychiatric disease such as major depression, anxiety disorder, panic disorder, and so on.
- 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
- 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
- Use of any nonselective, irreversible MAO inhibitor
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00902421
Start Date
January 1 2007
End Date
July 1 2009
Last Update
August 26 2010
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea