Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00730535
• Date of registration: 07/08/2008
• Primary sponsor: Samsung Medical Center
• Public title: Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
• Scientific 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
• Date of first enrolment: August 2006
• Target sample size: 173
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00730535
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Kyu-Sung Lee, Ph.D
• Affiliation: Samsung Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Female aged 18=and =80 years

2. Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary
Sensation Scale) over 2 times per day

3. Symptoms of urinary frequency (= 8 micturitions per 24 hours) as verified by baseline
micturition diary.

4. Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or
frequency for =6 months.

5. Ability and willingness to correctly complete the micturition diary and questionnaire

6. 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:

1. Clinical significant stress incontinence as determined by the investigator and
confirmed for female patients by a cough provocation test

2. An average volume voided of > 200 ml per micturition as verified on the baseline
micturition diary

3. Total daily urine volume of > 3000 ml as verified on the baseline micturition diary

4. 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

5. Any condition that is a contraindication for anticholinergic treatment, including
uncontrolled narrow-angled glaucoma, urinary retention or gastric retention

6. Symptomatic acute urinary tract infection (UTI) during the run-in period

7. Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the
last year

8. Diagnosed or suspected interstitial cystitis

9. Uninvestigated hematuria or hematuria secondary to malignant disease.

10. Clinically significant bladder outlet obstruction defined by clinical symptoms and
investigator's opinion according to local standard of care

11. Patients with marked cystocele or other clinically significant pelvic prolapse.

12. On an unstable dosage of any drug with anticholinergic side effects, or expected to
start such treatment during the study

13. 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

14. 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

15. An indwelling catheter or practicing intermittent self-catheterization

16. Use of any investigational drug within 2 months preceding the start of the study

17. Patients with chronic constipation or history of severe constipation

18. Pregnant or nursing women

19. 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).

20. Patients who have bladder cancer

21. Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide
antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents
(e.g. ketoconazole, itraconazole, micronazole).

22. Any other condition which, in the opinion of the investigator, makes the patient
unsuitable for inclusion



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: Tolterodine

Drug: Tolterodine 6

Primary Outcome(s)

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]

Secondary Outcome(s)

Micturition diary efficacy parameters [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]

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]

Secondary ID(s)

2005-08-069

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer