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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00902421

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Selective serotonin reuptake inhibitors Drug: Antimuscarinics	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of SSRI in Overactive Bladder Patients; a 3-month, Prospective, Open-label, Comparative Study

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antimuscarinics	Drug: Antimuscarinics Antimuscarinics for 3 months
Experimental: Selective serotonin reuptake inhibitors Selective serotonin reuptake inhibitor	Drug: Selective serotonin reuptake inhibitors escitalopram 10mg once daily for 3 months Other Names: Lexapro®

Arm

Intervention/Treatment

Active Comparator: Antimuscarinics

Drug: Antimuscarinics

Antimuscarinics for 3 months

Experimental: Selective serotonin reuptake inhibitors

Selective serotonin reuptake inhibitor

Drug: Selective serotonin reuptake inhibitors

escitalopram 10mg once daily for 3 months

Other Names:

Lexapro®

Outcome Measures

Primary Outcome Measures

Percentage change in urgency episodes/24 hrs [3 months of medication]

Secondary Outcome Measures

Micturition diary efficacy parameters [3 months of medication]
Quality of life parameters [3 months of medication]
Patient perceptions [3 months of medication]
Psychologic parameters [3 months of medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

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 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