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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730535
• Other study ID #: 2005-08-069
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• 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:

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

Related Conditions & MeSH terms

• Overactive Bladder
• Recurrence
• Urinary Bladder, Overactive

Intervention

Drug:
• Tolterodine
Extended release tolterodine tartrate 4 mg, once daily, for 1 months
• Tolterodine
Extended release tolterodine tartrate 4 mg, once daily, for 3 months
• Tolterodine 6
Extended release tolterodine tartrate 4 mg, once daily, for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Holy Family Hospital, The Catholic University of Korea	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Irwon-dong	Seoul
Korea, Republic of	Asan Medical Center, Ulsan College of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
KYU-SUNG LEE	Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors and relapse rate of the OAB symptoms after drug discontinuation		from baseline (treatment completion) to 1, 3 month after drug discontinuation
Secondary	Micturition diary efficacy parameters		from baseline (treatment completion) to 1, 3 month after drug discontinuation
Secondary	Quality of life parameters: change in total score and subscale scores of OAB-questionnaire		from baseline (treatment completion) to 1, 3 month after drug discontinuation
Secondary	Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment		from baseline (treatment completion) to 1, 3 month after drug discontinuation