Overactive BladderPhase 4NCT00730535
Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
A Phase 4 study testing Tolterodine and Tolterodine 6 in people with Overactive Bladder, run by KYU-SUNG LEE at 4 sites in South Korea.
Trial summary
This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month. 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?
- Tolterodine and Tolterodine 6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Aug 2006to 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
- Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) over 2 times per day
- Symptoms of urinary frequency (≥ 8 micturitions per 24 hours) as verified by baseline micturition diary.
- Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or frequency for ≥6 months.
- 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
- 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
Show all 22Show fewer
- 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
- Use of any other drugs for the treatment of overactive bladder (e.g. anticholinergics except tolterodine) 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
- Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole).
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Holy Family Hospital, The Catholic University of Korea
Gyeonggi-do
Samsung Medical Center
Irwon-dong, Seoul, 135-710
Asan Medical Center, Ulsan College of Medicine
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial
This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.
Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.
Read the detailed description
Primary Objective:
- To investigate the risk factors of OAB symptom relapse and retreatment in patients who showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.
Secondary Objective:
- To investigate the change of the patient perception and quality of life after antimuscarinic discontinuation
- To find the rate of patients who have OAB symptom relapse.
- To find the risk factors of patients who want retreatment.
- To find the rate of patients who want retreatment.
- Conditions
- Overactive Bladder
- Being tested
- Tolterodine, Tolterodine 6
- Keywords
- Overactive bladder, Tolterodine,Symptoms Relapse, Predictor
- 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.
TolterodineDrug
Also called Detrusitol ER 4mg
Extended release tolterodine tartrate 4 mg, once daily, for 1 months
TolterodineDrug
Also called Detrusitol ER 4mg
Extended release tolterodine tartrate 4 mg, once daily, for 3 months
Tolterodine 6Drug
Also called Detrusitol ER 4mg
Extended release tolterodine tartrate 4 mg, once daily, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Tolterodine 1 | Experimental | Not described Receives: Drug: Tolterodine |
| Toterodine 3 | Experimental | Not described Receives: Drug: Tolterodine |
| Tolterodine 6 | Experimental | Not described Receives: Drug: Tolterodine 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors and relapse rate of the OAB symptoms after drug discontinuation
Measured: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Secondary outcomes (3)
Micturition diary efficacy parameters
Measured: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Quality of life parameters: change in total score and subscale scores of OAB-questionnaire
Measured: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment
Measured: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2006
- 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- KYU-SUNG LEE
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730535
- Sponsor's protocol ID
- 2005-08-069
- Status last verified
- Apr 2011
- First submitted
- 7 Aug 2008
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT00730535
- Acronym / sponsor ID
- 2005-08-069
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Tolterodine,Symptoms Relapse, Predictor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- KYU-SUNG LEEUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Aug 2008 (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.
This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.
Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.
Detailed description
Primary Objective:
- To investigate the risk factors of OAB symptom relapse and retreatment in patients who showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.
Secondary Objective:
- To investigate the change of the patient perception and quality of life after antimuscarinic discontinuation
- To find the rate of patients who have OAB symptom relapse.
- To find the risk factors of patients who want retreatment.
- To find the rate of patients who want retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tolterodine 1 | Experimental | Drug: Tolterodine |
| Toterodine 3 | Experimental | Drug: Tolterodine |
| Tolterodine 6 | Experimental | Drug: Tolterodine 6 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female aged 18≤and ≤80 years
- Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) over 2 times per day
- Symptoms of urinary frequency (≥ 8 micturitions per 24 hours) as verified by baseline micturition diary.
- Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or frequency for ≥6 months.
- Ability and willingness to correctly complete the micturition diary and questionnaire
Key exclusion criteria (22 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
- 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
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 |
|---|---|---|
| TolterodineAlso: Detrusitol ER 4mgExtended release tolterodine tartrate 4 mg, once daily, for 1 months | Drug | Tolterodine 1 |
| TolterodineAlso: Detrusitol ER 4mgExtended release tolterodine tartrate 4 mg, once daily, for 3 months | Drug | Toterodine 3 |
| Tolterodine 6Also: Detrusitol ER 4mgExtended release tolterodine tartrate 4 mg, once daily, for 6 months | Drug | Tolterodine 6 |
Primary outcome
Risk factors and relapse rate of the OAB symptoms after drug discontinuation
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
3 secondary outcomes
Micturition diary efficacy parameters
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Quality of life parameters: change in total score and subscale scores of OAB-questionnaire
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
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 2 Dec 2019.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolterodine and Tolterodine 6 in people with Overactive Bladder, run by KYU-SUNG LEE at 4 sites 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 6 inclusion and 22 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Risk factors and relapse rate of the OAB symptoms after drug discontinuation (time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation). 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 2 Dec 2019.