A 24-WEEK, MULTICENTRE TRIAL, COMPRISING A 12-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE FOLLOWED BY A 12-WEEK OPEN-LABEL PHASE, TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
- Conditions
- Treatment of overactive bladder with symptoms of frequency, urgency, and urgencyincontinence (Some patients will also have urgency urinary incontinence (UUI)).MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2007-007087-17-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 790
1. Male or female outpatients =65 years old.
2. Overactive bladder symptoms (subject-reported) for =3 months prior to Screening/Enrolment visit (Visit 1) according to ICS guidelines.
3. Mean urinary frequency of =8 micturitions per 24 hours as verified by the micturition diary prior to Randomization/Baseline visit (Visit 2).
4. Mean number of Urgency episodes =3 per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Bladder Sensation Scale rating =3).
5. Rate their bladder as causing Some Moderate Problems”, Severe Problems”, or Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire at Baseline/Visit 2.
6. Able and willing to complete the micturition diaries and all trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures.
7. Mini-Mental State Examination Score of =20.
8. Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits.
9. All women who are enrolled into this study must be post menopausal as assessed by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any condition that would contraindicate their usage of Fesoterodine including: hypersensitivity to the active substance (Fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
2. Predominant Stress Incontinence. Stress urinary incontinence as determined/estimated by the investigator.
3. Stage 3 or greater pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure).
4. Transurethral resection of the prostate (TURP) or bladder (TURB)) and other minor surgery (eg, cystoscopic procedures) performed within the past 6 months or history of any major lower urinary tract surgery (eg, incontinence surgery or radical prostatectomy) at any time.
5. A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, clinical suspicion of prostate carcinoma, known mullerian duct cysts, radiation cystitis, or genito-urinary tuberculosis.
6. Active bladder stones. Patients with a previous history of bladder stones may be included.
7. Previous history of acute urinary retention requiring catheterisation, clinically significant bladder outflow obstruction or severe voiding difficulties in the judgment of the investigator.
8. Use of an indwelling catheter or an intermittent self-catheterization program.
9. Active urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year. Subjects with a UTI detected at screening may be treated (while remaining on study as part of an extended screening period) and retested 2 weeks after the subject has finished treatment.
10. Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 2.
11. Multiple sclerosis or spinal cord injury.
12. Treatment with antimuscarinic OAB medication within 2 weeks prior to Visit 2, including any preparation containing:
• darifenacin, oxybutynin, propiverine, tolterodine and trospium.
13. Treatment with solifenacin within 3 weeks prior to Visit 2.
14. Intermittent or unstable use of diuretics or alpha blockers, or initiation of such treatment(s) within 2 weeks prior to Visit 2.
15. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 2.
16. Participated in any clinical trial or received any investigational drug within 4 weeks prior to Visit 2.
17. Has any current malignancy except:
a. Those >5 years ago without recurrence.
b. Excised basal cell carcinoma or squamous cell carcinoma of skin.
18. Other severe or acute medical condition (including newly diagnosed diabetes mellitus or newly diagnosed hypertension requiring treatment, or major hematological or cardiovascular conditions) or psychological condition or social circumstances that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of the study results or may impair ability to participate reliably in the trial, or may increase the risk to themselves or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method