Overactive BladderPhase 4NCT00902421
Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients
A Phase 4 study testing Selective serotonin reuptake inhibitors and Antimuscarinics in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Selective serotonin reuptake inhibitors and Antimuscarinics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of SSRI in Overactive Bladder Patients; a 3-month, Prospective, Open-label, Comparative Study
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.
Read the 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
- Conditions
- Overactive Bladder
- Being tested
- Selective serotonin reuptake inhibitors, Antimuscarinics
- Keywords
- Overactive bladder, SSRI, Antimuscarinics
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective serotonin reuptake inhibitorsDrug
Also called Lexapro®
escitalopram 10mg once daily for 3 months
AntimuscarinicsDrug
Antimuscarinics for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Antimuscarinics | Active comparator | Not described Receives: Drug: Antimuscarinics |
| Selective serotonin reuptake inhibitors | Experimental | Selective serotonin reuptake inhibitor Receives: Drug: Selective serotonin reuptake inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in urgency episodes/24 hrs
Measured: 3 months of medication
Secondary outcomes (4)
Micturition diary efficacy parameters
Measured: 3 months of medication
Quality of life parameters
Measured: 3 months of medication
Patient perceptions
Measured: 3 months of medication
Psychologic parameters
Measured: 3 months of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902421
- Sponsor's protocol ID
- 2006-08-047
- Status last verified
- Aug 2010
- First submitted
- 14 May 2009
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SSRI in Overactive Bladder Patients; a 3-month, Prospective, Open-label, Comparative Study
- ClinicalTrials.gov ID
- NCT00902421
- Acronym / sponsor ID
- 2006-08-047
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, SSRI, Antimuscarinics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimuscarinics | Active comparator | Drug: Antimuscarinics |
| Selective serotonin reuptake inhibitors | Experimental | Drug: Selective serotonin reuptake inhibitorsSelective serotonin reuptake inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective serotonin reuptake inhibitorsAlso: Lexapro®escitalopram 10mg once daily for 3 months | Drug | Selective serotonin reuptake inhibitors |
| AntimuscarinicsAntimuscarinics for 3 months | Drug | Antimuscarinics |
Primary outcome
Percentage change in urgency episodes/24 hrs
Time frame: 3 months of medication
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective serotonin reuptake inhibitors and Antimuscarinics in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in urgency episodes/24 hrs (time frame: 3 months of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.