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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902421
• Other study ID #: 2006-08-047
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2009
• Last updated: August 24, 2010
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Selective serotonin reuptake inhibitors
escitalopram 10mg once daily for 3 months
• Antimuscarinics
Antimuscarinics for 3 months

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in urgency episodes/24 hrs		3 months of medication	No
Secondary	Micturition diary efficacy parameters		3 months of medication	Yes
Secondary	Quality of life parameters		3 months of medication	Yes
Secondary	Patient perceptions		3 months of medication	Yes
Secondary	Psychologic parameters		3 months of medication	Yes