A Randomized, Double Blind, Placebo Controlled Detrol La Add-On To Alpha-Blocker Study in men with persistent Overactive Bladder symptoms of urinary frequency and urgency with/without urgency incontinence after previous monotherapy with alpha blocker. - NA
- Conditions
- Overactive Bladder in MenMedDRA version: 8.0Level: LLTClassification code 10020853
- Registration Number
- EUCTR2005-004452-13-SK
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 608
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1.Men aged 40 years and above (with no upper limit of age)
2.On a stable dose of an alpha-blocker for at least 1 month
3.Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by:
a.Mean urinary frequency =8 times/24 hours
b.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)
4.A rating of the bladder condition at Baseline (visit 2) prior to randomization as Some Moderate Problems”, Severe Problems”, or Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire
5.The ability and willingness to correctly complete the micturition diary and various questionnaires, comply with scheduled visits and comply with trial procedures
6.The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits
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
Subjects presenting with any of the following will not be included in the trial:
1.Previous history of acute urinary retention requiring catheterization
2.A post void residual urinary volume greater than 200mls at Screening (visit 1)
3.Poor detrusor function or clinically relevant bladder outlet obstruction based on investigator’s judgment as shown in a flow rate and residual volume measurement at Screening (visit 1)
4.A 5-alpha reductase inhibitor if started less than 6 months prior to Screening (visit 1)
5.Urinary tract infection (UTI), including bacterial prostatitis, confirmed by a positive urine test or recurrent UTI defined as being treated for >3 episodes of symptomatic UTI in the past 12 months
6.A known history of bladder outlet obstruction due to: vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
7.A known history of uninvestigated haematuria, interstitial cystitis, genitor-urinary tuberculosis, bladder calculi or detrusor-sphincter dyssynergia
8.Previous history of prostatic surgery/intervention (including minimally invasive treatments), or other major urethral and/or bladder surgery or if subjects have any AEs requiring prostate surgery/intervention to relieve bladder outlet flow obstruction
9.History or suspicion of prostate cancer including a serum PSA (prostate specific antigen) concentration of greater than 10 ng/ml on repeat testing
10.History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
11.Any condition which, in the opinion of the investigator, makes the patient unsuitable, or with contraindications for inclusion, to either tolterodine ER or the background alpha blocker medication according to the approved product labeling for each drug in each country
12.Concomitant overt peripheral and central neurologic diseases, such as spinal cord injury or multiple sclerosis
13.Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine
14.Expectation of initiating treatment with any other drug for OAB or any drug with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects during the trial
15.Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (i.e., ketoconazole, itraconazole), protease inhibitors, or the expectation to start such a treatment during the trial
16.Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days
17.Use of any electrostimulation or bladder training in the past 30 days
18.Use of an indwelling catheter or an intermittent self-catheterization program
19.Use of any other investigational drug in the past 2 months
20.Treatment with an anti-cholinergic within the past 30 days
21.Intermittent or unstable use of diuretics throughout study duration. Treatment with diuretics initiated within 2 weeks prior to randomization is not permitted
22.A documented record of =20 mmHg postural decrease in systolic blood pressure (or) History of postural hypotension or syncope in the judgment of the investigator based on local standards of
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