Overactive Bladder in Men MedDRA version: 8.0 Level: LLT Classification code 10020853
Conditions
Interventions
Product Name: Detrol® LA
Product Code: PNU-200583
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tolterodine Tartrate
Current Sponsor code: PNU-200583
Concentration unit: mg milligram(s)
Concentr
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the additional benefit of ‘Add-On’ tolterodine L-tartrate ER (Detrol LA®), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence as assessed by the change in the Patient Perception of Bladder Condition (PPBC) after 12 weeks of treatment.;Secondary Objective: To evaluate the additional benefit of ‘Add-On’ tolterodine L-tartrate ER vs. placebo, to ABT in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: On OAB symptoms as assessed by 5-day voiding bladder diaries including Urinary Sensation Scale On symptoms as assessed by the IPSS On patient perception of treatment benefit as assessed by the PPTBQ On proportion of patients who experienced a change from baseline in PPBC after 4 and 12 weeks of treatment On bothersome QoL symptoms as assessed by the OBQ On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire On patient satisfaction with medication as assessed by the OBTSQ On nocturia bothersome measure as assessed by the Nocturia Quality-of-Life Questionnaire To evaluate the safety and tolerability of ‘Add-On’ tolterodine L-tartrate ER vs. placebo, to ABT in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence ;Primary end point(s): ·The primary efficacy measure is the proportion of patients who improved from baseline in Patient Perception of Bladder Condition at Week 12 | — |
Countries
Denmark, Germany, Italy, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed