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Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902421
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : August 26, 2010
Information provided by:
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE May 14, 2009
First Posted Date  ICMJE May 15, 2009
Last Update Posted Date August 26, 2010
Study Start Date  ICMJE January 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
Percentage change in urgency episodes/24 hrs [ Time Frame: 3 months of medication ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00902421 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
  • Micturition diary efficacy parameters [ Time Frame: 3 months of medication ]
  • Quality of life parameters [ Time Frame: 3 months of medication ]
  • Patient perceptions [ Time Frame: 3 months of medication ]
  • Psychologic parameters [ Time Frame: 3 months of medication ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients
Official Title  ICMJE Efficacy and Safety of SSRI in Overactive Bladder Patients; a 3-month, Prospective, Open-label, Comparative Study
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 with urinary incontinence. Depression also occurs in other conditions associated with urinary urge incontinence, such as aging and dementia, and in neurologic disorders such as normal pressure hydrocephalus. Correction of some neurologic disorders eliminates both depression and urge incontinence. Although chronic medical disorders such as urge incontinence may lead to depression, an alternative hypothesis is that these two conditions share a common neurochemical pathogenesis. Lowering monoamines such as serotonin and noradrenaline in the central nervous system (CNS) leads to depression and urinary frequency and a hyperactive bladder in experimental animals. Thus, depression may not only be the result of persistent urinary incontinence, but individuals with altered CNS monoamines could manifest both depression and an overactive bladder. The latter condition may lead to urge incontinence, urinary frequency, urgency, or enuresis. Uncovering further evidence for such a linkage could serve as the basis for the development of genetic markers and novel therapeutic interventions for these two conditions.

In this study, the investigators will evaluate the efficacy and safety of SSRI on OAB patients who does not respond to the antimuscarinic agents.

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 treatment with antimuscarinic agents and who then treated with SSRI (escitalopram) for 3 months.
  • Secondary Objectives

    • To investigate the change of patient perception of urgency and bladder condition
    • To investigate the change of patient perception of quality of life
    • To investigate the change of psychologic parameters
    • To investigate the patient perception of treatment benefit
    • To find the predictive factors of patients who respond to the 3 month-treatment with escitalopram
    • To explore the efficacy of escitalopram on the tolerability and safety
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Selective serotonin reuptake inhibitors
    escitalopram 10mg once daily for 3 months
    Other Name: Lexapro®
  • Drug: Antimuscarinics
    Antimuscarinics for 3 months
Study Arms  ICMJE
  • Active Comparator: Antimuscarinics
    Intervention: Drug: Antimuscarinics
  • Experimental: Selective serotonin reuptake inhibitors
    Selective serotonin reuptake inhibitor
    Intervention: Drug: Selective serotonin reuptake inhibitors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2009)
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1. Mean urinary frequency ≥8 times/24 hours
    2. 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 Criteria:

  • 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
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 NCT00902421
Other Study ID Numbers  ICMJE 2006-08-047
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyu-Sung Lee/Professor, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date August 2010

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