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

NCT00902421 | Completed Phase 4 DMC

• 1 other identifier: 2006-08-047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Overactive bladder; SSRI; Antimuscarinics

Outcome Measures

Primary Outcomes (1)

• Percentage change in urgency episodes/24 hrs

  3 months of medication

Secondary Outcomes (4)

• 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

Study Arms (2)

Antimuscarinics

ACTIVE COMPARATOR

Drug: Antimuscarinics

Selective serotonin reuptake inhibitors

EXPERIMENTAL

Selective serotonin reuptake inhibitor

Drug: Selective serotonin reuptake inhibitors

Interventions

Selective serotonin reuptake inhibitors DRUG

escitalopram 10mg once daily for 3 months

Also known as: Lexapro®

Selective serotonin reuptake inhibitors

Antimuscarinics DRUG

Antimuscarinics for 3 months

Antimuscarinics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Selective Serotonin Reuptake Inhibitors; Escitalopram; Muscarinic Antagonists

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cholinergic Antagonists; Cholinergic Agents

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 26, 2010

Record last verified: 2010-08

Locations

KR (1)